Identity
- Trade Name
- NexGen® FDA UDI
- Generic Name
- Uncoated knee tibia prosthesis, metallic FDA UDI
- Model / Reference
- 00-5916-070-01 FDA UDI
Identifiers
- Catalog Number
- 00-5916-070-01 FDA UDI
- Primary DI / UDI-DI
- 00889024000438 FDA UDI
- PMA Number
- P060037 FDA UDI
- FDA Product Code
- NJL FDA UDI
- GMDN Term
- Uncoated knee tibia prosthesis, metallic FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Uncoated knee tibia prosthesis, metallic
NexGen® by Zimmer, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Uncoated knee tibia prosthesis, metallic.
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Cleared under the same submission
P060037 also covers:
- NexGen® — Zimmer, Inc.
- NexGen® Complete Knee Solution — Zimmer, Inc.
- NexGen® Complete Knee Solution — Zimmer, Inc.
- NexGen® Complete Knee Solution — Zimmer, Inc.
- NexGen® Complete Knee Solution — Zimmer, Inc.
- NexGen® Complete Knee Solution — Zimmer, Inc.
- NexGen® Complete Knee Solution — Zimmer, Inc.
- NexGen® Complete Knee Solution — Zimmer, Inc.
- NexGen® Complete Knee Solution — Zimmer, Inc.
- NexGen® Complete Knee Solution — Zimmer, Inc.
- NexGen® Legacy® — Zimmer, Inc.
- NexGen® Legacy® — Zimmer, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Zimmer, Inc.
Sources (1)
- FDA UDI cc61ac26-e586-4485-b365-abef46430f39 36 fields · synced Jun 8, 2026