Identity
- Trade Name
- Oxford Partial Knee System FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- Signature Femoral Drill Guide FDA UDI
- Model / Reference
- 42-411446 FDA UDI
- Description
- Signature Femoral Drill Guide FDA UDI
Identifiers
- Catalog Number
- 42-411446 FDA UDI
- Primary DI / UDI-DI
- 00880304510159 FDA UDI
- PMA Number
- P010014 FDA UDI
- FDA Product Code
- NRA FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Orthopaedic prosthesis implantation positioning instrument, reusable
Oxford Partial Knee System by Biomet Orthopedics, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic prosthesis implantation positioning instrument, reusable.
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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 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
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI 4bbdff37-8097-4c27-bbca-3bddf22add04 37 fields · synced Jun 8, 2026