Identity
- Trade Name
- Profemur FDA UDI
- Generic Name
- Press-fit hip femur prosthesis, modular FDA UDI
- Device Name
- PROFEMUR NECK 8DG VAR/VAL SHORT FDA UDI
- Model / Reference
- PHA01252 FDA UDI
- Description
- PROFEMUR NECK 8DG VAR/VAL SHORT FDA UDI
Identifiers
- Catalog Number
- PHA01252 FDA UDI
- Primary DI / UDI-DI
- M684PHA012521 FDA UDI
- FDA Product Code
- MRA FDA UDILWJ FDA UDI
- GMDN Term
- Press-fit hip femur prosthesis, modular FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 888.3360 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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 1.8 Millimeter FDA UDI
Category: Press-fit hip femur prosthesis, modular
Profemur by MicroPort Orthopedics Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Press-fit hip femur prosthesis, modular.
- Alloclassic® Zweymüller® — Zimmer, Inc. · Class II
- Wagner SL Revision® — Zimmer, Inc. · Class II
- VerSys® — Zimmer, Inc. · Class II
- Wagner Cone Prosthesis® — Zimmer, Inc. · Class II
- SUMMIT — DEPUY ORTHOPAEDICS, INC. · Class II
- Alloclassic® Zweymüller® — Zimmer, Inc. · Class II
- UniSyn Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- VerSys® — 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 III | Pending data |
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Manufacturer
- Manufacturer
- MicroPort Orthopedics Inc.
Sources (1)
- FDA UDI 9de53afe-f8d2-4454-beed-2098efb710e9 36 fields · synced Jun 9, 2026