Identity
- Trade Name
- NexGen® FDA UDI
- Generic Name
- Uncoated knee tibia prosthesis, polyethylene FDA UDI
- Model / Reference
- 5966-04-12 FDA UDI
Identifiers
- Catalog Number
- 00-5966-004-12 FDA UDI
- Primary DI / UDI-DI
- 00889024212336 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Uncoated knee tibia prosthesis, polyethylene FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 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
Dimensions & Sizes
- Size
- Height — 12 Millimeter FDA UDI
Category: Uncoated knee tibia prosthesis, polyethylene
NexGen® by Zimmer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Uncoated knee tibia prosthesis, polyethylene.
- Freedom — MAXX ORTHOPEDICS INC. · Class II
- JOURNEY — Smith & Nephew, Inc. · Class II
- JII — Smith & Nephew, Inc. · Class II
- World Knee Vit-E CR All Poly Tibia — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- Freedom — MAXX ORTHOPEDICS INC. · Class II
- Gemini SL — WALDEMAR LINK GmbH & Co. KG · Class II
- TC-PLUS Primary — Smith & Nephew, Inc. · Class II
- Triathlon — Howmedica Osteonics Corp. · Class II
Cleared under the same submission
K173057 also covers:
- Gender Solutions® Natural-Knee® — Zimmer, Inc.
- Gender Solutions® Natural-Knee® — Zimmer, Inc.
- Gender Solutions® Natural-Knee® — Zimmer, Inc.
- Gender Solutions® Natural-Knee® Prolong® — Zimmer, Inc.
- Gender Solutions® Natural-Knee® Prolong® — Zimmer, Inc.
- Gender Solutions® Natural-Knee® Prolong® — Zimmer, Inc.
- Natural-Knee® — Zimmer, Inc.
- Natural-Knee® — Zimmer, Inc.
- Natural-Knee® — Zimmer, Inc.
- Natural-Knee® — Zimmer, Inc.
- Natural-Knee® — Zimmer, Inc.
- Natural-Knee® — Zimmer, Inc.
K933785 also covers:
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zimmer, Inc.
Sources (1)
- FDA UDI fe48eca1-18a7-40b7-99b5-9025bef00372 36 fields · synced May 30, 2026