Identity
- Trade Name
- FINN KNEE SYSTEM FDA UDI
- Generic Name
- Uncoated femoral stem prosthesis, one-piece FDA UDI
- Model / Reference
- 180045 FDA UDI
Identifiers
- Catalog Number
- 180045 FDA UDI
- Primary DI / UDI-DI
- 00880304268906 FDA UDI
- 510(k) Number
- K861826 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Uncoated femoral stem prosthesis, one-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 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: Uncoated femoral stem prosthesis, one-piece
Finn Knee System by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Uncoated femoral stem prosthesis, one-piece.
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- Alteon — Exactech, Inc. · Class II
- OrthoMedFlex — ORTHOMEDFLEX LLC · Class II
- Novation — Exactech, Inc. · Class II
- Evolve Masters — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- Consensus Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- Acumatch C Series — Exactech, Inc. · Class II
Cleared under the same submission
K861826 also covers:
- FINN KNEE SYSTEM — Biomet Orthopedics, Inc.
- FINN KNEE SYSTEM — Biomet Orthopedics, Inc.
- FINN KNEE SYSTEM — Biomet Orthopedics, Inc.
- FINN KNEE SYSTEM — Biomet Orthopedics, Inc.
- FINN KNEE SYSTEM — Biomet Orthopedics, Inc.
- FINN KNEE SYSTEM — Biomet Orthopedics, Inc.
- FINN KNEE SYSTEM — Biomet Orthopedics, Inc.
- FINN KNEE SYSTEM — Biomet Orthopedics, Inc.
- FINN KNEE 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 dc3c6e10-03a1-40fc-b38e-7bee43341722 36 fields · synced May 30, 2026