Identity
- Trade Name
- Oxford Partial Knee System FDA UDI
- Generic Name
- Knee tibia prosthesis trial, reusable FDA UDI
- Device Name
- Phase 3 Trial Bearing FDA UDI
- Model / Reference
- 32-420388 FDA UDI
- Description
- Phase 3 Trial Bearing FDA UDI
Identifiers
- Catalog Number
- 32-420388 FDA UDI
- Primary DI / UDI-DI
- 05019279484294 FDA UDI
- PMA Number
- P010014 FDA UDI
- FDA Product Code
- NRA FDA UDI
- GMDN Term
- Knee tibia prosthesis trial, reusable 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
No
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: Knee tibia prosthesis trial, reusable
Oxford Partial Knee System by Biomet Uk Ltd — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- U2™ Knee — UNITED ORTHOPEDIC CORP. · Class II
- ACS® — implantcast GmbH · Class I
- SIGMA — DEPUY ORTHOPAEDICS, INC. · Class I
- SIGMA — DEPUY ORTHOPAEDICS, INC. · Class I
- INSTRUMENT — Howmedica Osteonics Corp. · Class I
Cleared under the same submission
P010014 also covers:
- Oxford Partial Knee System — Biomet Orthopedics, Inc.
- Oxford Partial Knee System — Biomet Orthopedics, Inc.
- Oxford Partial Knee System — Biomet Orthopedics, Inc.
- Oxford Partial Knee System — Biomet Uk Ltd
- Oxford Partial Knee System — Biomet Uk Ltd
- Oxford Partial Knee System — Biomet Uk Ltd
- Oxford Partial Knee System — Biomet Uk Ltd
- Oxford Partial Knee System — Biomet Uk Ltd
- Oxford Partial Knee System — Biomet Uk Ltd
- Oxford Partial Knee System — Biomet Uk Ltd
- Oxford Partial Knee System — Biomet Uk Ltd
- Oxford Partial Knee System — Biomet Uk Ltd
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
- Biomet Uk Ltd
Sources (1)
- FDA UDI 3dbdd8b6-6641-4de4-b666-0eab5b9d7976 37 fields · synced May 31, 2026