Identity
- Trade Name
- MODULAR HEAD FDA UDI
- Generic Name
- Femoral head prosthesis trial FDA UDI
- Model / Reference
- 31-482593 FDA UDI
Identifiers
- Catalog Number
- 31-482593 FDA UDI
- Primary DI / UDI-DI
- 00880304320741 FDA UDI
- FDA Product Code
- HWT FDA UDI
- GMDN Term
- Femoral head prosthesis trial 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: Femoral head prosthesis trial
Modular Head by Biomet Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Femoral head prosthesis trial.
- Modal Total Hip System — MODAL MANUFACTURING LLC · Class II
- CHARNLEY — DEPUY INTERNATIONAL LTD · Class I
- Klassic Femoral Head Trial — TOTAL JOINT ORTHOPEDICS, INC. · Class I
- AcuMatch — Exactech, Inc. · Class I
- AcuMatch — Exactech, Inc. · Class I
- NovoHip Total Hip System — Novosource, Inc. · Class II
- INSTRUMENT — Howmedica Osteonics Corp. · Class II
- Trail Head — ADLER ORTHO SPA · Class I
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 Orthopedics, Inc.
Sources (1)
- FDA UDI 972e5625-fb00-4753-a139-b139a5529ac8 35 fields · synced May 30, 2026