Identity
- Trade Name
- Profemur FDA UDI
- Generic Name
- Press-fit hip femur prosthesis, modular FDA UDI
- Device Name
- PROFEMUR 215MM STEM BOWED/TAPER SIZE 18 FDA UDI
- Model / Reference
- PPW38048 FDA UDI
- Description
- PROFEMUR 215MM STEM BOWED/TAPER SIZE 18 FDA UDI
Identifiers
- Catalog Number
- PPW38048 FDA UDI
- Primary DI / UDI-DI
- M684PPW380481 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 — 215 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- MicroPort Orthopedics Inc.
Sources (1)
- FDA UDI 69b05847-2e99-4bac-83d5-5c033b8a3a5c 36 fields · synced Jun 9, 2026