Identity
- Trade Name
- ORTHOPEDIC SALVAGE SYSTEM (OSS) FDA UDI
- Generic Name
- Tibial insert FDA UDI
- Model / Reference
- 161033 FDA UDI
Identifiers
- Catalog Number
- 161033 FDA UDI
- Primary DI / UDI-DI
- 00880304250949 FDA UDI
- 510(k) Number
- K021260 FDA UDI
- FDA Product Code
- KRO FDA UDI
- GMDN Term
- Tibial insert FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3510 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: Tibial insert
Orthopedic Salvage System (oss) by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K021260 also covers:
- ORTHOPEDIC SALVAGE SYSTEM (OSS) — Biomet Orthopedics, Inc.
- ORTHOPEDIC SALVAGE SYSTEM (OSS) — Biomet Orthopedics, Inc.
- ORTHOPEDIC SALVAGE SYSTEM (OSS) — Biomet Orthopedics, Inc.
- ORTHOPEDIC SALVAGE SYSTEM (OSS) — Biomet Orthopedics, Inc.
- ORTHOPEDIC SALVAGE SYSTEM (OSS) — Biomet Orthopedics, Inc.
- ORTHOPEDIC SALVAGE SYSTEM (OSS) — Biomet Orthopedics, Inc.
- ORTHOPEDIC SALVAGE SYSTEM (OSS) — Biomet Orthopedics, Inc.
- ORTHOPEDIC SALVAGE SYSTEM (OSS) — Biomet Orthopedics, Inc.
- ORTHOPEDIC SALVAGE SYSTEM (OSS) — Biomet Orthopedics, Inc.
- ORTHOPEDIC SALVAGE SYSTEM (OSS) — Biomet Orthopedics, Inc.
- ORTHOPEDIC SALVAGE SYSTEM (OSS) — Biomet Orthopedics, Inc.
- ORTHOPEDIC SALVAGE SYSTEM (OSS) — 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 df22fe9c-c4e0-407a-bc91-15e231a13b30 36 fields · synced Jun 8, 2026