Identity
- Trade Name
- OXFORD FIXED FDA UDI
- Generic Name
- Surgical implant template, reusable FDA UDI
- Model / Reference
- 32-423335 FDA UDI
Identifiers
- Catalog Number
- 32-423335 FDA UDI
- Primary DI / UDI-DI
- 00880304609877 FDA UDI
- 510(k) Number
- K122277 FDA UDI
- FDA Product Code
- HRY FDA UDI
- GMDN Term
- Surgical implant template, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3530 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical implant template, reusable
Oxford Fixed by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical implant template, reusable.
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- Tranquil-C™ — NEXUS SPINE, L.L.C. · Class I
- VFT — Ldr Spine USA · Class II
- Tranquil-C™ — NEXUS SPINE, L.L.C. · Class I
Cleared under the same submission
K122277 also covers:
- OXFORD FIXED — Biomet Orthopedics, Inc.
- OXFORD FIXED — Biomet Orthopedics, Inc.
- OXFORD FIXED — Biomet Orthopedics, Inc.
- OXFORD FIXED — Biomet Orthopedics, Inc.
- OXFORD FIXED — Biomet Orthopedics, Inc.
- OXFORD LATERAL INSTRUMENTS — Biomet Orthopedics, Inc.
- OXFORD LATERAL INSTRUMENTS — Biomet Orthopedics, Inc.
- OXFORD LATERAL INSTRUMENTS — Biomet Orthopedics, Inc.
- OXFORD LATERAL INSTRUMENTS — Biomet Orthopedics, Inc.
- OXFORD LATERAL INSTRUMENTS — Biomet Orthopedics, Inc.
- OXFORD LATERAL INSTRUMENTS — Biomet Orthopedics, Inc.
- OXFORD LATERAL INSTRUMENTS — Biomet Orthopedics, 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 |
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Manufacturer
- Manufacturer
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI a4a9e76a-3282-4abb-9720-e812a055d99d 36 fields · synced Jun 1, 2026