Identity
- Trade Name
- NexGen® FDA UDI
- Generic Name
- Knee arthroplasty wedge FDA UDI
- Model / Reference
- 5988-02-26 FDA UDI
Identifiers
- Catalog Number
- 00-5988-002-26 FDA UDI
- Primary DI / UDI-DI
- 00889024220157 FDA UDI
- FDA Product Code
- HSX FDA UDIJWH FDA UDIKRO FDA UDI
- GMDN Term
- Knee arthroplasty wedge FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3520 FDA UDI888.3560 FDA UDI888.3510 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
Category: Knee arthroplasty wedge
NexGen® by Zimmer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K152494 also covers:
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.
K862632 also covers:
K946150 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 |
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Manufacturer
- Manufacturer
- Zimmer, Inc.
Sources (1)
- FDA UDI 0f6e8180-be74-4d1f-837b-5b28558b03a5 36 fields · synced May 30, 2026