Vanguard Complete Knee System SSI002642

GUDID 00889024506787

Biomet Orthopedics, LLC

Knee tibia prosthesis trial

• Primary Device ID: 00889024506787
• NIH Device Record Key: 391647f1-e957-4de4-98c0-00dd9ae2010c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vanguard Complete Knee System
• Version Model Number: SSI002642
• Catalog Number: SSI002642
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter
• Height: 13 Millimeter
• Length: 79 Millimeter
• Width: 83 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024506787 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113550

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

[00889024506787]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2018-03-26

On-Brand Devices [Vanguard Complete Knee System]

• 00880304989948: SSI003228
• 00880304989931: SSI003227
• 00880304989924: SSI003226
• 00880304989917: SSI003225
• 00880304989900: SSI003224
• 00880304989894: SSI003223
• 00880304865716: SSI002373
• 00880304865709: SSI002372
• 00880304865693: SSI002359
• 00880304865686: SSI002358
• 00880304865679: SSI002357
• 00880304865662: SSI002356
• 00880304865655: SSI002347
• 00880304865648: SSI002346
• 00880304865631: SSI002345
• 00880304856332: SSI001058
• 00880304856325: SSI001057
• 00880304560765: 195952
• 00880304560758: 195951
• 00880304560741: 195950
• 00880304560734: 195949
• 00880304560727: 195948
• 00880304560710: 195947
• 00880304560703: 195946
• 00880304560697: 195945
• 00880304560680: 195944
• 00880304560673: 195943
• 00880304560666: 195942
• 00880304560659: 195941
• 00880304560642: 195940
• 00880304560635: 195939
• 00880304560628: 195938
• 00880304560611: 195937
• 00880304560604: 195936
• 00880304560598: 195935
• 00880304560581: 195934
• 00880304560574: 195933
• 00880304560567: 195932
• 00880304560550: 195931
• 00880304560543: 195930
• 00880304560536: 195929
• 00880304560529: 195928
• 00880304560512: 195927
• 00880304560505: 195926
• 00880304560499: 195925
• 00880304560482: 195924
• 00880304560475: 195923
• 00880304560468: 195922
• 00880304560451: 195921
• 00880304560444: 195920