Identity
- Trade Name
- OSS™ Orthopedic Salvage System FDA UDI
- Generic Name
- Coated knee femur prosthesis FDA UDI
- Model / Reference
- 150357 FDA UDI
Identifiers
- Catalog Number
- 150357 FDA UDI
- Primary DI / UDI-DI
- 00880304238855 FDA UDI
- 510(k) Number
- K002757 FDA UDI
- FDA Product Code
- JDI FDA UDIKRO FDA UDILPH FDA UDILZO FDA UDIKWY FDA UDIKWZ FDA UDIKWT FDA UDIMEH FDA UDI
- GMDN Term
- Coated knee femur prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3350 FDA UDI888.3510 FDA UDI888.3358 FDA UDI888.3353 FDA UDI888.3390 FDA UDI888.3310 FDA UDI888.3650 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
Yes
FDA UDI
Category: Coated knee femur prosthesis
OSS™ Orthopedic Salvage System by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coated knee femur prosthesis.
- PHYSICA POROUS PS — Limacorporate · Class II
- GMK Primary Total Knee System — Medacta International · Class II
- PHYSICA POROUS KR — Limacorporate · Class II
- PERSONA™ Trabecular Metal™ — Zimmer, Inc. · Class II
- PERSONA™ Trabecular Metal™ — Zimmer, Inc. · Class II
- Persona® PPS® — Zimmer, Inc. · Class II
- Genflex2 Total Knee System — GLOBUS MEDICAL, INC. · Class II
- SIGMA — DEPUY (IRELAND) · Class II
Cleared under the same submission
K002757 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.
- OSS™ Orthopedic Salvage System — Biomet Orthopedics, Inc.
- OSS™ Orthopedic Salvage System — Biomet Orthopedics, Inc.
- OSS™ Orthopedic Salvage System — Biomet Orthopedics, Inc.
- OSS™ Orthopedic Salvage System — Biomet Orthopedics, Inc.
- OSS™ Orthopedic Salvage System — 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 a7ef3907-67e4-41a4-bd5d-bdee398895a8 36 fields · synced Jun 1, 2026