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Page 1: Technical File - 008
Page 2: Technical File - 008

Technical File No. TF-008 SPINE TRAUMA BRACING OSTEOBIOLOGICS Product Group: Spine – Cervical Implants - VueLock® Anterior Cervical Plate System Rev. C Effective: 01/11/10

PROPRIETARY & CONFIDENTIAL BIOMET® FILE NO. DD0126 REV. D NOTE: MASTER maintained electronically within the Agile System, printed document is an UNCONTROLLED COPY. Page 7 of 60

2.3 PRODUCT IDENTIFICATION SCHEDULE VUELOCK® ANTERIOR CERVICAL PLATE SYSTEM

Manufacturing resides at:

Biomet – New Jersey 100 Interpace Parkway Parsippany, NJ 07054 USA

973.299.9300

www.biometspinal.com

A=Active I=Inactive V=Variant

Stat

us

Catalog-Product-REF No. Description Size Manuf.

831XXE VueLock® One Level Plate, 18MM Width N/A Biomet NJ A 832XXE VueLock Two Level Plate, 18MM Width “ A 833XXE VueLock Three Level Plate, 18MM Width “ A 834XXE VueLock Four Level Plate, 18MM Width “ A 631XX VueLock One Level Plate, 21MM Width “ A 632XX VueLock Two Level Plate, 21MM Width “ A 633XX VueLock Three Level Plate, 21MM Width “ A 634XX VueLock Four Level Plate, 21MM Width “ A Where XX = Plate Length in MM - Where E = Sterile - 630XX Self-Tapping and Self-Drilling Bone Screws “ A Where XX = Random Sequential Number -

ITEMIZED PRODUCT IDENTIFICATION SCHEDULE VUELOCK Anterior Cervical One Level Plates, 18MM Width (Non-Sterile)

83112 ONE LEVEL 12MM PLATE 12MM Biomet NJ A 83114 ONE LEVEL 14MM PLATE 14MM Biomet NJ A 83116 ONE LEVEL 16MM PLATE 16MM Biomet NJ A 83118 ONE LEVEL 18MM PLATE 18MM Biomet NJ A 83120 ONE LEVEL 20MM PLATE 20MM Biomet NJ A 83122 ONE LEVEL 22MM PLATE 22MM Biomet NJ A 83124 ONE LEVEL 24MM PLATE 24MM Biomet NJ A 83126 ONE LEVEL 26MM PLATE 26MM Biomet NJ A 83128 ONE LEVEL 28MM PLATE 28MM Biomet NJ A 83130 ONE LEVEL 30MM PLATE 30MM Biomet NJ A 83132 ONE LEVEL 32MM PLATE 32MM Biomet NJ A 83134 ONE LEVEL 34MM PLATE 34MM Biomet NJ A 83136 ONE LEVEL 36MM PLATE 36MM Biomet NJ A

VUELOCK Anterior Cervical Two Level Plates, 18MM Width (Non-Sterile) 83224 TWO LEVEL 24MM PLATE 24MM Biomet NJ A 83226 TWO LEVEL 26MM PLATE 26MM Biomet NJ A 83228 TWO LEVEL 28MM PLATE 28MM Biomet NJ A 83230 TWO LEVEL 30MM PLATE 30MM Biomet NJ A 83232 TWO LEVEL 32MM PLATE 32MM Biomet NJ A 83234 TWO LEVEL 34MM PLATE 34MM Biomet NJ A 83236 TWO LEVEL 36MM PLATE 36MM Biomet NJ A 83238 TWO LEVEL 38MM PLATE 38MM Biomet NJ A 83240 TWO LEVEL 40MM PLATE 40MM Biomet NJ A

Page 3: Technical File - 008

Technical File No. TF-008 SPINE TRAUMA BRACING OSTEOBIOLOGICS Product Group: Spine – Cervical Implants - VueLock® Anterior Cervical Plate System Rev. C Effective: 01/11/10

PROPRIETARY & CONFIDENTIAL BIOMET® FILE NO. DD0126 REV. D NOTE: MASTER maintained electronically within the Agile System, printed document is an UNCONTROLLED COPY. Page 8 of 60

2.3 PRODUCT IDENTIFICATION SCHEDULE VUELOCK® ANTERIOR CERVICAL PLATE SYSTEM

Manufacturing resides at:

Biomet – New Jersey 100 Interpace Parkway Parsippany, NJ 07054 USA

973.299.9300

www.biometspinal.com

A=Active I=Inactive V=Variant

Stat

us

Catalog-Product-REF No. Description Size Manuf.

831XXE VueLock® One Level Plate, 18MM Width N/A Biomet NJ A 832XXE VueLock Two Level Plate, 18MM Width “ A 833XXE VueLock Three Level Plate, 18MM Width “ A 834XXE VueLock Four Level Plate, 18MM Width “ A 631XX VueLock One Level Plate, 21MM Width “ A 632XX VueLock Two Level Plate, 21MM Width “ A 633XX VueLock Three Level Plate, 21MM Width “ A 634XX VueLock Four Level Plate, 21MM Width “ A Where XX = Plate Length in MM - Where E = Sterile - 630XX Self-Tapping and Self-Drilling Bone Screws “ A Where XX = Random Sequential Number -

ITEMIZED PRODUCT IDENTIFICATION SCHEDULE VUELOCK Anterior Cervical Two Level Plates, 18MM Width (Non-Sterile) Cont’d

83242 TWO LEVEL 42MM PLATE 42MM Biomet NJ A 83244 TWO LEVEL 44MM PLATE 44MM Biomet NJ A 83246 TWO LEVEL 46MM PLATE 46MM Biomet NJ A 83248 TWO LEVEL 48MM PLATE 48MM Biomet NJ A 83250* TWO LEVEL 50MM PLATE 50MM Biomet NJ A 83252 TWO LEVEL 52MM PLATE 52MM Biomet NJ A 83254 TWO LEVEL 54MM PLATE 54MM Biomet NJ A 83256 TWO LEVEL 56MM PLATE 56MM Biomet NJ A 83258 TWO LEVEL 58MM PLATE 58MM Biomet NJ A 83260 TWO LEVEL 60MM PLATE 60MM Biomet NJ A 83262 TWO LEVEL 62MM PLATE 62MM Biomet NJ A 83264 TWO LEVEL 64MM PLATE 64MM Biomet NJ A 83266 TWO LEVEL 66MM PLATE 66MM Biomet NJ A 83268 TWO LEVEL 68MM PLATE 68MM Biomet NJ A 83270 TWO LEVEL 70MM PLATE 70MM Biomet NJ A

VUELOCK Anterior Cervical Three Level Plates, 18MM Width (Non-Sterile) 83344 THREE LEVEL 44MM PLATE 44MM Biomet NJ A 83346 THREE LEVEL 46MM PLATE 46MM Biomet NJ A 83348 THREE LEVEL 48MM PLATE 48MM Biomet NJ A 83350 THREE LEVEL 50MM PLATE 50MM Biomet NJ A 83352 THREE LEVEL 52MM PLATE 52MM Biomet NJ A 83354 THREE LEVEL 54MM PLATE 54MM Biomet NJ A 83356 THREE LEVEL 56MM PLATE 56MM Biomet NJ A 83358 THREE LEVEL 58MM PLATE 58MM Biomet NJ A

83360 THREE LEVEL 60MM PLATE 60MM Biomet NJ A 83362 THREE LEVEL 62MM PLATE 62MM Biomet NJ A 83364 THREE LEVEL 64MM PLATE 64MM Biomet NJ A 83366 THREE LEVEL 66MM PLATE 66MM Biomet NJ A

Page 4: Technical File - 008

Technical File No. TF-008 SPINE TRAUMA BRACING OSTEOBIOLOGICS Product Group: Spine – Cervical Implants - VueLock® Anterior Cervical Plate System Rev. C Effective: 01/11/10

PROPRIETARY & CONFIDENTIAL BIOMET® FILE NO. DD0126 REV. D NOTE: MASTER maintained electronically within the Agile System, printed document is an UNCONTROLLED COPY. Page 9 of 60

2.3 PRODUCT IDENTIFICATION SCHEDULE VUELOCK® ANTERIOR CERVICAL PLATE SYSTEM

Manufacturing resides at:

Biomet – New Jersey 100 Interpace Parkway Parsippany, NJ 07054 USA

973.299.9300

www.biometspinal.com

A=Active I=Inactive V=Variant

Stat

us

Catalog-Product-REF No. Description Size Manuf.

831XXE VueLock® One Level Plate, 18MM Width N/A Biomet NJ A 832XXE VueLock Two Level Plate, 18MM Width “ A 833XXE VueLock Three Level Plate, 18MM Width “ A 834XXE VueLock Four Level Plate, 18MM Width “ A 631XX VueLock One Level Plate, 21MM Width “ A 632XX VueLock Two Level Plate, 21MM Width “ A 633XX VueLock Three Level Plate, 21MM Width “ A 634XX VueLock Four Level Plate, 21MM Width “ A Where XX = Plate Length in MM - Where E = Sterile - 630XX Self-Tapping and Self-Drilling Bone Screws “ A Where XX = Random Sequential Number -

ITEMIZED PRODUCT IDENTIFICATION SCHEDULE VUELOCK Anterior Cervical Three Level Plates, 18MM Width (Non-Sterile) Cont’d

83368 THREE LEVEL 68MM PLATE 68MM Biomet NJ A 83370 THREE LEVEL 70MM PLATE 70MM Biomet NJ A 83372 THREE LEVEL 72MM PLATE 72MM Biomet NJ A 83374 THREE LEVEL 74MM PLATE 74MM Biomet NJ A 83376 THREE LEVEL 76MM PLATE 76MM Biomet NJ A 83378 THREE LEVEL 78MM PLATE 78MM Biomet NJ A 83380 THREE LEVEL 80MM PLATE 80MM Biomet NJ A 83382 THREE LEVEL 82MM PLATE 82MM Biomet NJ A 83384 THREE LEVEL 84MM PLATE 84MM Biomet NJ A 83386 THREE LEVEL 86MM PLATE 86MM Biomet NJ A 83388 THREE LEVEL 88MM PLATE 88MM Biomet NJ A 83390 THREE LEVEL 90MM PLATE 90MM Biomet NJ A

VUELOCK Anterior Cervical Four Level Plates, 18MM Width (Non-Sterile) 83460 FOUR LEVEL 60MM PLATE 60MM Biomet NJ A 83462 FOUR LEVEL 62MM PLATE 62MM Biomet NJ A 83464 FOUR LEVEL 64MM PLATE 64MM Biomet NJ A 83466 FOUR LEVEL 66MM PLATE 66MM Biomet NJ A 83468 FOUR LEVEL 68MM PLATE 68MM Biomet NJ A 83470 FOUR LEVEL 70MM PLATE 70MM Biomet NJ A 83472 FOUR LEVEL 72MM PLATE 72MM Biomet NJ A 83474 FOUR LEVEL 74MM PLATE 74MM Biomet NJ A 83476 FOUR LEVEL 76MM PLATE 76MM Biomet NJ A 83478 FOUR LEVEL 78MM PLATE 78MM Biomet NJ A 83480 FOUR LEVEL 80MM PLATE 80MM Biomet NJ A 83482 FOUR LEVEL 82MM PLATE 82MM Biomet NJ A 83484 FOUR LEVEL 84MM PLATE 84MM Biomet NJ A

Page 5: Technical File - 008

Technical File No. TF-008 SPINE TRAUMA BRACING OSTEOBIOLOGICS Product Group: Spine – Cervical Implants - VueLock® Anterior Cervical Plate System Rev. C Effective: 01/11/10

PROPRIETARY & CONFIDENTIAL BIOMET® FILE NO. DD0126 REV. D NOTE: MASTER maintained electronically within the Agile System, printed document is an UNCONTROLLED COPY. Page 10 of 60

2.3 PRODUCT IDENTIFICATION SCHEDULE VUELOCK® ANTERIOR CERVICAL PLATE SYSTEM

Manufacturing resides at:

Biomet – New Jersey 100 Interpace Parkway Parsippany, NJ 07054 USA

973.299.9300

www.biometspinal.com

A=Active I=Inactive V=Variant

Stat

us

Catalog-Product-REF No. Description Size Manuf.

831XXE VueLock® One Level Plate, 18MM Width N/A Biomet NJ A 832XXE VueLock Two Level Plate, 18MM Width “ A 833XXE VueLock Three Level Plate, 18MM Width “ A 834XXE VueLock Four Level Plate, 18MM Width “ A 631XX VueLock One Level Plate, 21MM Width “ A 632XX VueLock Two Level Plate, 21MM Width “ A 633XX VueLock Three Level Plate, 21MM Width “ A 634XX VueLock Four Level Plate, 21MM Width “ A Where XX = Plate Length in MM - Where E = Sterile - 630XX Self-Tapping and Self-Drilling Bone Screws “ A Where XX = Random Sequential Number -

ITEMIZED PRODUCT IDENTIFICATION SCHEDULE VUELOCK Anterior Cervical Four Level Plates, 18MM Width (Non-Sterile) Cont’d

83486 FOUR LEVEL 86MM PLATE 86MM Biomet NJ A 83488 FOUR LEVEL 88MM PLATE 88MM Biomet NJ A 83490 FOUR LEVEL 90MM PLATE 90MM Biomet NJ A 83492 FOUR LEVEL 92MM PLATE 92MM Biomet NJ A 83494 FOUR LEVEL 94MM PLATE 94MM Biomet NJ A 83496 FOUR LEVEL 96MM PLATE 96MM Biomet NJ A 83498 FOUR LEVEL 98MM PLATE 98MM Biomet NJ A

834100 FOUR LEVEL 100MM PLATE 100MM Biomet NJ A 834102 FOUR LEVEL 102MM PLATE 102MM Biomet NJ A 834104 FOUR LEVEL 104MM PLATE 104MM Biomet NJ A 834106 FOUR LEVEL 106MM PLATE 106MM Biomet NJ A 834108 FOUR LEVEL 108MM PLATE 108MM Biomet NJ A 834110 FOUR LEVEL 110MM PLATE 110MM Biomet NJ A

VUELOCK Anterior Cervical One Level Plates, 21MM Width (Non-Sterile) 63112 ONE LEVEL 12MM PLATE 12MM Biomet NJ A 63114 ONE LEVEL 14MM PLATE 14MM Biomet NJ A 63116 ONE LEVEL 16MM PLATE 16MM Biomet NJ A 63118 ONE LEVEL 18MM PLATE 18MM Biomet NJ A 63120 ONE LEVEL 20MM PLATE 20MM Biomet NJ A 63122 ONE LEVEL 22MM PLATE 22MM Biomet NJ A 63124 ONE LEVEL 24MM PLATE 24MM Biomet NJ A 63126 ONE LEVEL 26MM PLATE 26MM Biomet NJ A 63128 ONE LEVEL 28MM PLATE 28MM Biomet NJ A 63130 ONE LEVEL 30MM PLATE 30MM Biomet NJ A 63132 ONE LEVEL 32MM PLATE 32MM Biomet NJ A 63134 ONE LEVEL 34MM PLATE 34MM Biomet NJ A 63136 ONE LEVEL 36MM PLATE 36MM Biomet NJ A

Page 6: Technical File - 008

Technical File No. TF-008 SPINE TRAUMA BRACING OSTEOBIOLOGICS Product Group: Spine – Cervical Implants - VueLock® Anterior Cervical Plate System Rev. C Effective: 01/11/10

PROPRIETARY & CONFIDENTIAL BIOMET® FILE NO. DD0126 REV. D NOTE: MASTER maintained electronically within the Agile System, printed document is an UNCONTROLLED COPY. Page 11 of 60

2.3 PRODUCT IDENTIFICATION SCHEDULE VUELOCK® ANTERIOR CERVICAL PLATE SYSTEM

Manufacturing resides at:

Biomet – New Jersey 100 Interpace Parkway Parsippany, NJ 07054 USA

973.299.9300

www.biometspinal.com

A=Active I=Inactive V=Variant

Stat

us

Catalog-Product-REF No. Description Size Manuf.

831XXE VueLock® One Level Plate, 18MM Width N/A Biomet NJ A 832XXE VueLock Two Level Plate, 18MM Width “ A 833XXE VueLock Three Level Plate, 18MM Width “ A 834XXE VueLock Four Level Plate, 18MM Width “ A 631XX VueLock One Level Plate, 21MM Width “ A 632XX VueLock Two Level Plate, 21MM Width “ A 633XX VueLock Three Level Plate, 21MM Width “ A 634XX VueLock Four Level Plate, 21MM Width “ A Where XX = Plate Length in MM - Where E = Sterile - 630XX Self-Tapping and Self-Drilling Bone Screws “ A Where XX = Random Sequential Number -

ITEMIZED PRODUCT IDENTIFICATION SCHEDULE VUELOCK Anterior Cervical Two Level Plates, 21MM Width (Non-Sterile)

63224 TWO LEVEL 24MM PLATE 24MM Biomet NJ A 63226 TWO LEVEL 26MM PLATE 26MM Biomet NJ A 63228 TWO LEVEL 28MM PLATE 28MM Biomet NJ A 63230 TWO LEVEL 30MM PLATE 30MM Biomet NJ A 63232 TWO LEVEL 32MM PLATE 32MM Biomet NJ A 63234 TWO LEVEL 34MM PLATE 34MM Biomet NJ A 63236 TWO LEVEL 36MM PLATE 36MM Biomet NJ A 63238 TWO LEVEL 38MM PLATE 38MM Biomet NJ A 63240 TWO LEVEL 40MM PLATE 40MM Biomet NJ A 63242 TWO LEVEL 42MM PLATE 42MM Biomet NJ A 63244 TWO LEVEL 44MM PLATE 44MM Biomet NJ A 63246 TWO LEVEL 46MM PLATE 46MM Biomet NJ A 63248 TWO LEVEL 48MM PLATE 48MM Biomet NJ A 63250 TWO LEVEL 50MM PLATE 50MM Biomet NJ A 63252 TWO LEVEL 52MM PLATE 52MM Biomet NJ A 63254 TWO LEVEL 54MM PLATE 54MM Biomet NJ A 63256 TWO LEVEL 56MM PLATE 56MM Biomet NJ A 63258 TWO LEVEL 58MM PLATE 58MM Biomet NJ A 63260 TWO LEVEL 60MM PLATE 60MM Biomet NJ A 63262 TWO LEVEL 62MM PLATE 62MM Biomet NJ A 63264 TWO LEVEL 64MM PLATE 64MM Biomet NJ A 63266 TWO LEVEL 66MM PLATE 66MM Biomet NJ A 63268 TWO LEVEL 68MM PLATE 68MM Biomet NJ A 63270 TWO LEVEL 70MM PLATE 70MM Biomet NJ A

Page 7: Technical File - 008

Technical File No. TF-008 SPINE TRAUMA BRACING OSTEOBIOLOGICS Product Group: Spine – Cervical Implants - VueLock® Anterior Cervical Plate System Rev. C Effective: 01/11/10

PROPRIETARY & CONFIDENTIAL BIOMET® FILE NO. DD0126 REV. D NOTE: MASTER maintained electronically within the Agile System, printed document is an UNCONTROLLED COPY. Page 12 of 60

2.3 PRODUCT IDENTIFICATION SCHEDULE VUELOCK® ANTERIOR CERVICAL PLATE SYSTEM

Manufacturing resides at:

Biomet – New Jersey 100 Interpace Parkway Parsippany, NJ 07054 USA

973.299.9300

www.biometspinal.com

A=Active I=Inactive V=Variant

Stat

us

Catalog-Product-REF No. Description Size Manuf.

831XXE VueLock® One Level Plate, 18MM Width N/A Biomet NJ A 832XXE VueLock Two Level Plate, 18MM Width “ A 833XXE VueLock Three Level Plate, 18MM Width “ A 834XXE VueLock Four Level Plate, 18MM Width “ A 631XX VueLock One Level Plate, 21MM Width “ A 632XX VueLock Two Level Plate, 21MM Width “ A 633XX VueLock Three Level Plate, 21MM Width “ A 634XX VueLock Four Level Plate, 21MM Width “ A Where XX = Plate Length in MM - Where E = Sterile - 630XX Self-Tapping and Self-Drilling Bone Screws “ A Where XX = Random Sequential Number -

ITEMIZED PRODUCT IDENTIFICATION SCHEDULE VUELOCK Anterior Cervical Three Level Plates, 21MM Width (Non-Sterile)

63348 THREE LEVEL 48MM PLATE 48MM Biomet NJ A 63350 THREE LEVEL 50MM PLATE 50MM Biomet NJ A 63352 THREE LEVEL 52MM PLATE 52MM Biomet NJ A 63354 THREE LEVEL 54MM PLATE 54MM Biomet NJ A 63356 THREE LEVEL 56MM PLATE 56MM Biomet NJ A 63358 THREE LEVEL 58MM PLATE 58MM Biomet NJ A 63360 THREE LEVEL 60MM PLATE 60MM Biomet NJ A 63362 THREE LEVEL 62MM PLATE 62MM Biomet NJ A 63364 THREE LEVEL 64MM PLATE 64MM Biomet NJ A 63366 THREE LEVEL 66MM PLATE 66MM Biomet NJ A 63368 THREE LEVEL 68MM PLATE 68MM Biomet NJ A

VUELOCK Anterior Cervical Three Level Plates, 21MM Width (Non-Sterile) 63370 THREE LEVEL 70MM PLATE 70MM Biomet NJ A 63372 THREE LEVEL 72MM PLATE 72MM Biomet NJ A 63374 THREE LEVEL 74MM PLATE 74MM Biomet NJ A 63376 THREE LEVEL 76MM PLATE 76MM Biomet NJ A 63378 THREE LEVEL 78MM PLATE 78MM Biomet NJ A 63380 THREE LEVEL 80MM PLATE 80MM Biomet NJ A 63382 THREE LEVEL 82MM PLATE 82MM Biomet NJ A 63384 THREE LEVEL 84MM PLATE 84MM Biomet NJ A 63386 THREE LEVEL 86MM PLATE 86MM Biomet NJ A 63388 THREE LEVEL 88MM PLATE 88MM Biomet NJ A 63390 THREE LEVEL 90MM PLATE 90MM Biomet NJ A

Page 8: Technical File - 008

Technical File No. TF-008 SPINE TRAUMA BRACING OSTEOBIOLOGICS Product Group: Spine – Cervical Implants - VueLock® Anterior Cervical Plate System Rev. C Effective: 01/11/10

PROPRIETARY & CONFIDENTIAL BIOMET® FILE NO. DD0126 REV. D NOTE: MASTER maintained electronically within the Agile System, printed document is an UNCONTROLLED COPY. Page 13 of 60

2.3 PRODUCT IDENTIFICATION SCHEDULE VUELOCK® ANTERIOR CERVICAL PLATE SYSTEM

Manufacturing resides at:

Biomet – New Jersey 100 Interpace Parkway Parsippany, NJ 07054 USA

973.299.9300

www.biometspinal.com

A=Active I=Inactive V=Variant

Stat

us

Catalog-Product-REF No. Description Size Manuf.

831XXE VueLock® One Level Plate, 18MM Width N/A Biomet NJ A 832XXE VueLock Two Level Plate, 18MM Width “ A 833XXE VueLock Three Level Plate, 18MM Width “ A 834XXE VueLock Four Level Plate, 18MM Width “ A 631XX VueLock One Level Plate, 21MM Width “ A 632XX VueLock Two Level Plate, 21MM Width “ A 633XX VueLock Three Level Plate, 21MM Width “ A 634XX VueLock Four Level Plate, 21MM Width “ A Where XX = Plate Length in MM - Where E = Sterile - 630XX Self-Tapping and Self-Drilling Bone Screws “ A Where XX = Random Sequential Number -

ITEMIZED PRODUCT IDENTIFICATION SCHEDULE VUELOCK Anterior Cervical Four Level Plates, 21MM Width (Non-Sterile)

63464 FOUR LEVEL 64MM PLATE 64MM Biomet NJ A 63466 FOUR LEVEL 66MM PLATE 66MM Biomet NJ A 63468 FOUR LEVEL 68MM PLATE 68MM Biomet NJ A 63470 FOUR LEVEL 70MM PLATE 70MM Biomet NJ A 63472 FOUR LEVEL 72MM PLATE 72MM Biomet NJ A 63474 FOUR LEVEL 74MM PLATE 74MM Biomet NJ A 63476 FOUR LEVEL 76MM PLATE 76MM Biomet NJ A 63478 FOUR LEVEL 78MM PLATE 78MM Biomet NJ A 63480 FOUR LEVEL 80MM PLATE 80MM Biomet NJ A 63482 FOUR LEVEL 82MM PLATE 82MM Biomet NJ A 63484 FOUR LEVEL 84MM PLATE 84MM Biomet NJ A 63486 FOUR LEVEL 86MM PLATE 86MM Biomet NJ A 63488 FOUR LEVEL 88MM PLATE 88MM Biomet NJ A 63490 FOUR LEVEL 90MM PLATE 90MM Biomet NJ A 63492 FOUR LEVEL 92MM PLATE 92MM Biomet NJ A 63494 FOUR LEVEL 94MM PLATE 94MM Biomet NJ A 63496 FOUR LEVEL 96MM PLATE 96MM Biomet NJ A 63498 FOUR LEVEL 98MM PLATE 98MM Biomet NJ A

634104 FOUR LEVEL 104MM PLATE 104MM Biomet NJ A 634106 FOUR LEVEL 106MM PLATE 106MM Biomet NJ A 634108 FOUR LEVEL 108MM PLATE 108MM Biomet NJ A 634110 FOUR LEVEL 110MM PLATE 110MM Biomet NJ A

Page 9: Technical File - 008

Technical File No. TF-008 SPINE TRAUMA BRACING OSTEOBIOLOGICS Product Group: Spine – Cervical Implants - VueLock® Anterior Cervical Plate System Rev. C Effective: 01/11/10

PROPRIETARY & CONFIDENTIAL BIOMET® FILE NO. DD0126 REV. D NOTE: MASTER maintained electronically within the Agile System, printed document is an UNCONTROLLED COPY. Page 14 of 60

2.3 PRODUCT IDENTIFICATION SCHEDULE VUELOCK® ANTERIOR CERVICAL PLATE SYSTEM

Manufacturing resides at:

Biomet – New Jersey 100 Interpace Parkway Parsippany, NJ 07054 USA

973.299.9300

www.biometspinal.com

A=Active I=Inactive V=Variant

Stat

us

Catalog-Product-REF No. Description Size Manuf.

831XXE VueLock® One Level Plate, 18MM Width N/A Biomet NJ A 832XXE VueLock Two Level Plate, 18MM Width “ A 833XXE VueLock Three Level Plate, 18MM Width “ A 834XXE VueLock Four Level Plate, 18MM Width “ A 631XX VueLock One Level Plate, 21MM Width “ A 632XX VueLock Two Level Plate, 21MM Width “ A 633XX VueLock Three Level Plate, 21MM Width “ A 634XX VueLock Four Level Plate, 21MM Width “ A Where XX = Plate Length in MM - Where E = Sterile - 630XX Self-Tapping and Self-Drilling Bone Screws “ A Where XX = Random Sequential Number -

ITEMIZED PRODUCT IDENTIFICATION SCHEDULE VUELOCK Anterior Cervical Plate System Kits (Non-Sterile)

80050S VUELOCK ANTERIOR CERVICAL PLATE KIT N/A Biomet NJ A 80950S VUELOCK STANDARD IMPLANT AND INSTRUMENT KIT N/A Biomet NJ A 80975S VUELOCK 4-LEVEL IMPLANT KIT N/A Biomet NJ A

VUELOCK Self-Tapping Bone Screws (Non-Sterile) 63001 3.5MM X 12MM SELF-TAPPING BONE SCREW 12MM Biomet NJ A 63003 3.5MM X 14MM SELF-TAPPING BONE SCREW 14MM Biomet NJ A 63005 3.5MM X 16MM SELF-TAPPING BONE SCREW 16MM Biomet NJ A 63007 3.5MM X 18MM SELF-TAPPING BONE SCREW 18MM Biomet NJ A 63009 3.5MM X 20MM SELF-TAPPING BONE SCREW 20MM Biomet NJ A 63011 3.5MM X 22MM SELF-TAPPING BONE SCREW 22MM Biomet NJ A 63013 3.5MM X 24MM SELF-TAPPING BONE SCREW 24MM Biomet NJ A 63025 4.0MM X 12MM SELF-TAPPING BONE SCREW 12MM Biomet NJ A 63027 4.0MM X 14MM SELF-TAPPING BONE SCREW 14MM Biomet NJ A 63029 4.0MM X 16MM SELF-TAPPING BONE SCREW 16MM Biomet NJ A 63031 4.0MM X 18MM SELF-TAPPING BONE SCREW 18MM Biomet NJ A 63033 4.0MM X 20MM SELF-TAPPING BONE SCREW 20MM Biomet NJ A 63035 4.0MM X 22MM SELF-TAPPING BONE SCREW 22MM Biomet NJ A 63037 4.0MM X 24MM SELF-TAPPING BONE SCREW 24MM Biomet NJ A 63050 5.0MM X 12MM SELF-TAPPING BONE SCREW 12MM Biomet NJ A 63052 5.0MM X 14MM SELF-TAPPING BONE SCREW 14MM Biomet NJ A 63054 5.0MM X 16MM SELF-TAPPING BONE SCREW 16MM Biomet NJ A 63056 5.0MM X 18MM SELF-TAPPING BONE SCREW 18MM Biomet NJ A 63058 5.0MM X 20MM SELF-TAPPING BONE SCREW 20MM Biomet NJ A 63060 5.0MM X 22MM SELF-TAPPING BONE SCREW 22MM Biomet NJ A 63062 5.0MM X 24MM SELF-TAPPING BONE SCREW 24MM Biomet NJ A

Page 10: Technical File - 008

Technical File No. TF-008 SPINE TRAUMA BRACING OSTEOBIOLOGICS Product Group: Spine – Cervical Implants - VueLock® Anterior Cervical Plate System Rev. C Effective: 01/11/10

PROPRIETARY & CONFIDENTIAL BIOMET® FILE NO. DD0126 REV. D NOTE: MASTER maintained electronically within the Agile System, printed document is an UNCONTROLLED COPY. Page 15 of 60

2.3 PRODUCT IDENTIFICATION SCHEDULE VUELOCK® ANTERIOR CERVICAL PLATE SYSTEM

Manufacturing resides at:

Biomet – New Jersey 100 Interpace Parkway Parsippany, NJ 07054 USA

973.299.9300

www.biometspinal.com

A=Active I=Inactive V=Variant

Stat

us

Catalog-Product-REF No. Description Size Manuf.

831XXE VueLock® One Level Plate, 18MM Width N/A Biomet NJ A 832XXE VueLock Two Level Plate, 18MM Width “ A 833XXE VueLock Three Level Plate, 18MM Width “ A 834XXE VueLock Four Level Plate, 18MM Width “ A 631XX VueLock One Level Plate, 21MM Width “ A 632XX VueLock Two Level Plate, 21MM Width “ A 633XX VueLock Three Level Plate, 21MM Width “ A 634XX VueLock Four Level Plate, 21MM Width “ A Where XX = Plate Length in MM - Where E = Sterile - 630XX Self-Tapping and Self-Drilling Bone Screws “ A Where XX = Random Sequential Number -

ITEMIZED PRODUCT IDENTIFICATION SCHEDULE VUELOCK Self Drilling Bone Screws (Non-Sterile)

63024 4.0MM X 12MM SELF-DRILLING BONE SCREW 12MM Biomet NJ A 63028 4.0MM X 14MM SELF-DRILLING BONE SCREW 14MM Biomet NJ A 63030 4.0MM X 16MM SELF-DRILLING BONE SCREW 16MM Biomet NJ A 63032* 4.0MM X 18MM SELF-DRILLING BONE SCREW 18MM Biomet NJ A 63034* 4.0MM X 20MM SELF-DRILLING BONE SCREW 20MM Biomet NJ A 63036* 4.0MM X 22MM SELF-DRILLING BONE SCREW 22MM Biomet NJ A 63038* 4.0MM X 24MM SELF-DRILLING BONE SCREW 24MM Biomet NJ A 63051 5.0MM X 12MM SELF-DRILLING BONE SCREW 12MM Biomet NJ A 63053 5.0MM X 14MM SELF-DRILLING BONE SCREW 14MM Biomet NJ A 63055 5.0MM X 16MM SELF-DRILLING BONE SCREW 16MM Biomet NJ A 63057* 5.0MM X 18MM SELF-DRILLING BONE SCREW 18MM Biomet NJ A 63059* 5.0MM X 20MM SELF-DRILLING BONE SCREW 20MM Biomet NJ A 63061* 5.0MM X 22MM SELF-DRILLING BONE SCREW 22MM Biomet NJ A 63063* 5.0MM X 24MM SELF-DRILLING BONE SCREW 24MM Biomet NJ A

VUELOCK Anterior Cervical One Level Plates, 18MM Width (Sterile) 83112E ONE LEVEL 12MM PLATE 12MM Biomet NJ A 83114E ONE LEVEL 14MM PLATE 14MM Biomet NJ A 83116E ONE LEVEL 16MM PLATE 16MM Biomet NJ A 83118E ONE LEVEL 18MM PLATE 18MM Biomet NJ A 83120E ONE LEVEL 20MM PLATE 20MM Biomet NJ A 83122E ONE LEVEL 22MM PLATE 22MM Biomet NJ A 83124E ONE LEVEL 24MM PLATE 24MM Biomet NJ A

VUELOCK Anterior Cervical Two Level Plates, 18MM Width (Sterile) 83226E TWO LEVEL 26MM PLATE 26MM Biomet NJ A 83228E TWO LEVEL 28MM PLATE 28MM Biomet NJ A

Page 11: Technical File - 008

Technical File No. TF-008 SPINE TRAUMA BRACING OSTEOBIOLOGICS Product Group: Spine – Cervical Implants - VueLock® Anterior Cervical Plate System Rev. C Effective: 01/11/10

PROPRIETARY & CONFIDENTIAL BIOMET® FILE NO. DD0126 REV. D NOTE: MASTER maintained electronically within the Agile System, printed document is an UNCONTROLLED COPY. Page 16 of 60

2.3 PRODUCT IDENTIFICATION SCHEDULE VUELOCK® ANTERIOR CERVICAL PLATE SYSTEM

Manufacturing resides at:

Biomet – New Jersey 100 Interpace Parkway Parsippany, NJ 07054 USA

973.299.9300

www.biometspinal.com

A=Active I=Inactive V=Variant

Stat

us

Catalog-Product-REF No. Description Size Manuf.

831XXE VueLock® One Level Plate, 18MM Width N/A Biomet NJ A 832XXE VueLock Two Level Plate, 18MM Width “ A 833XXE VueLock Three Level Plate, 18MM Width “ A 834XXE VueLock Four Level Plate, 18MM Width “ A 631XX VueLock One Level Plate, 21MM Width “ A 632XX VueLock Two Level Plate, 21MM Width “ A 633XX VueLock Three Level Plate, 21MM Width “ A 634XX VueLock Four Level Plate, 21MM Width “ A Where XX = Plate Length in MM - Where E = Sterile - 630XX Self-Tapping and Self-Drilling Bone Screws “ A Where XX = Random Sequential Number -

ITEMIZED PRODUCT IDENTIFICATION SCHEDULE VUELOCK Anterior Cervical Two Level Plates, 18MM Width (Sterile) cont’d

83230E TWO LEVEL 30MM PLATE 30MM Biomet NJ A 83232E TWO LEVEL 32MM PLATE 32MM Biomet NJ A 83234E TWO LEVEL 34MM PLATE 34MM Biomet NJ A 83236E TWO LEVEL 36MM PLATE 36MM Biomet NJ A 83238E TWO LEVEL 38MM PLATE 38MM Biomet NJ A 83240E TWO LEVEL 40MM PLATE 40MM Biomet NJ A 83242E TWO LEVEL 42MM PLATE 42MM Biomet NJ A

VUELOCK Anterior Cervical Three Level Plates, 18MM Width (Sterile) 83344E THREE LEVEL 44MM PLATE 44MM Biomet NJ A 83346E THREE LEVEL 46MM PLATE 46MM Biomet NJ A 83348E THREE LEVEL 48MM PLATE 48MM Biomet NJ A 83350E THREE LEVEL 50MM PLATE 50MM Biomet NJ A 83352E THREE LEVEL 52MM PLATE 52MM Biomet NJ A 83354E THREE LEVEL 54MM PLATE 54MM Biomet NJ A 83356E THREE LEVEL 56MM PLATE 56MM Biomet NJ A 83358E THREE LEVEL 58MM PLATE 58MM Biomet NJ A 83360E THREE LEVEL 60MM PLATE 60MM Biomet NJ A 83362E THREE LEVEL 62MM PLATE 62MM Biomet NJ A 83364E THREE LEVEL 64MM PLATE 64MM Biomet NJ A 83366E THREE LEVEL 66MM PLATE 66MM Biomet NJ A

VUELOCK Anterior Cervical Four Level Plates 18MM Width (Sterile) 83460E FOUR LEVEL 60MM PLATE 60MM Biomet NJ A 83464E FOUR LEVEL 64MM PLATE 64MM Biomet NJ A 83468E FOUR LEVEL 68MM PLATE 68MM Biomet NJ A 83472E FOUR LEVEL 72MM PLATE 72MM Biomet NJ A 83476E FOUR LEVEL 76MM PLATE 76MM Biomet NJ A 83480E FOUR LEVEL 80MM PLATE 80MM Biomet NJ A 83484E FOUR LEVEL 84MM PLATE 84MM Biomet NJ A 83488E FOUR LEVEL 88MM PLATE 88MM Biomet NJ A 83492E FOUR LEVEL 92MM PLATE 92MM Biomet NJ A

Page 12: Technical File - 008

Technical File No. TF-008 SPINE TRAUMA BRACING OSTEOBIOLOGICS Product Group: Spine – Cervical Implants - VueLock® Anterior Cervical Plate System Rev. C Effective: 01/11/10

PROPRIETARY & CONFIDENTIAL BIOMET® FILE NO. DD0126 REV. D NOTE: MASTER maintained electronically within the Agile System, printed document is an UNCONTROLLED COPY. Page 17 of 60

2.3 PRODUCT IDENTIFICATION SCHEDULE VUELOCK® ANTERIOR CERVICAL PLATE SYSTEM

Manufacturing resides at:

Biomet – New Jersey 100 Interpace Parkway Parsippany, NJ 07054 USA

973.299.9300

www.biometspinal.com

A=Active I=Inactive V=Variant

Stat

us

Catalog-Product-REF No. Description Size Manuf.

831XXE VueLock® One Level Plate, 18MM Width N/A Biomet NJ A 832XXE VueLock Two Level Plate, 18MM Width “ A 833XXE VueLock Three Level Plate, 18MM Width “ A 834XXE VueLock Four Level Plate, 18MM Width “ A 631XX VueLock One Level Plate, 21MM Width “ A 632XX VueLock Two Level Plate, 21MM Width “ A 633XX VueLock Three Level Plate, 21MM Width “ A 634XX VueLock Four Level Plate, 21MM Width “ A Where XX = Plate Length in MM - Where E = Sterile - 630XX Self-Tapping and Self-Drilling Bone Screws “ A Where XX = Random Sequential Number -

ITEMIZED PRODUCT IDENTIFICATION SCHEDULE VUELOCK Self-Tapping Bone Screws (Sterile)

63025E 4.0MM X 12MM SELF-TAPPING BONE SCREW 12MM Biomet NJ A 63027E 4.0MM X 14MM SELF-TAPPING BONE SCREW 14MM Biomet NJ A 63029E 4.0MM X 16MM SELF-TAPPING BONE SCREW 16MM Biomet NJ A 63031E 4.0MM X 18MM SELF-TAPPING BONE SCREW 18MM Biomet NJ A 63033E 4.0MM X 20MM SELF-TAPPING BONE SCREW 20MM Biomet NJ A 63035E 4.0MM X 22MM SELF-TAPPING BONE SCREW 22MM Biomet NJ A 63037E 4.0MM X 24MM SELF-TAPPING BONE SCREW 24MM Biomet NJ A 63050E 5.0MM X 12MM SELF-TAPPING BONE SCREW 12MM Biomet NJ A 63052E 5.0MM X 14MM SELF-TAPPING BONE SCREW 14MM Biomet NJ A 63053E 5.0MM X 14MM SELF-TAPPING BONE SCREW 14MM Biomet NJ A 63054E 5.0MM X 16MM SELF-TAPPING BONE SCREW 16MM Biomet NJ A 63056E 5.0MM X 18MM SELF-TAPPING BONE SCREW 18MM Biomet NJ A 63058E 5.0MM X 20MM SELF-TAPPING BONE SCREW 20MM Biomet NJ A 63060E 5.0MM X 22MM SELF-TAPPING BONE SCREW 22MM Biomet NJ A 63062E 5.0MM X 24MM SELF-TAPPING BONE SCREW 24MM Biomet NJ A

VUELOCK Self-Drilling Bone Screws (Sterile) 63024E 4.0MM X 12MM SELF-DRILLING BONE SCREW 12MM Biomet NJ A

63028E 4.0MM X 14MM SELF-DRILLING BONE SCREW 14MM Biomet NJ A 63030E 4.0MM X 16MM SELF-DRILLING BONE SCREW 16MM Biomet NJ A 63051E 5.0MM X 12MM SELF-DRILLING BONE SCREW 12MM Biomet NJ A 63055E 5.0MM X 16MM SELF-DRILLING BONE SCREW 16MM Biomet NJ A