Identity
- Trade Name
- NexGen® Complete Knee Solution FDA UDI
- Generic Name
- Tibial insert FDA UDI
- Model / Reference
- 00-5962-024-10 FDA UDI
Identifiers
- Catalog Number
- 00-5962-024-10 FDA UDI
- Primary DI / UDI-DI
- 00889024665811 FDA UDI
- FDA Product Code
- MBH FDA UDIJWH FDA UDI
- GMDN Term
- Tibial insert FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3565 FDA UDI888.3560 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
Yes
FDA UDI
Category: Tibial insert
NexGen® Complete Knee Solution by Zimmer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Tibial insert.
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Cleared under the same submission
K042271 also covers:
- 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® Complete Knee Solution — Zimmer, Inc.
- NexGen® Complete Knee Solution — Zimmer, Inc.
- NexGen® Complete Knee Solution — Zimmer, Inc.
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.
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 0ba3b101-58b2-45ff-b982-e894df4d3aaa 36 fields · synced May 30, 2026