Identity
- Trade Name
- UniSyn Hip System FDA UDI
- Generic Name
- Revision coated hip femur prosthesis FDA UDI
- Device Name
- Body, Calcar, Cementless, PC, Plasma, 28mm FDA UDI
- Model / Reference
- 3473-42800-A FDA UDI
- Description
- Body, Calcar, Cementless, PC, Plasma, 28mm FDA UDI
Identifiers
- Catalog Number
- 3473-42800-A FDA UDI
- Primary DI / UDI-DI
- 00840286837835 FDA UDI
- FDA Product Code
- JDI FDA UDI
- GMDN Term
- Revision coated hip femur prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3350 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
Yes
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: Revision coated hip femur prosthesis
The UniSyn Hip System is a revolutionary body, calcar, cementless, PC, Plasma, 28mm hip prosthesis designed for implantation in total hip replacement procedures. It features modular design, coated with porous materials to promote bone ingrowth and improve fixation.
Similar devices
Also classified as Revision coated hip femur prosthesis.
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- ZMR® — Zimmer, Inc. · Class II
- M-Vizion Femoral Revision System — Medacta International · Class II
- ZMR® — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Shalby Advanced Technologies, Inc.
Sources (1)
- FDA UDI f7958bb4-5953-4938-8b2e-67cd8cb8dfbf 35 fields · synced Jun 23, 2026