Identity
- Trade Name
- MAXIM KNEE SYSYEM FDA UDI
- Generic Name
- Knee femur prosthesis trial, reusable FDA UDI
- Model / Reference
- 32-345320 FDA UDI
Identifiers
- Catalog Number
- 32-345320 FDA UDI
- Primary DI / UDI-DI
- 05019279465057 FDA UDI
- FDA Product Code
- HWT FDA UDI
- GMDN Term
- Knee femur prosthesis trial, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4800 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
Yes
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: Knee femur prosthesis trial, reusable
Maxim Knee Sysyem by Biomet Uk Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Knee femur prosthesis trial, reusable.
- Lospa Modular Knee System — Corentec Co., Ltd · Class II
- OSS™ — Biomet Orthopedics, Inc. · Class II
- VANGUARD 360 INSTRUMENT — Biomet Orthopedics, Inc. · Class II
- VANGUARD(TM) PS FEMORAL TRIAL — Biomet Orthopedics, Inc. · Class II
- Natural-Knee® — Zimmer, Inc. · Class II
- NexGen® — Zimmer, Inc. · Class II
- LOSPA Knee System — Corentec Co., Ltd · Class II
- Persona® — Zimmer, Inc. · Class II
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biomet Uk Ltd
Sources (1)
- FDA UDI 439b3f22-ccf9-4cba-8b01-2f88533245e4 35 fields · synced May 30, 2026