Identity
- Trade Name
- UniSyn Hip System FDA UDI
- Generic Name
- Press-fit hip femur prosthesis, modular FDA UDI
- Device Name
- Stem, PLUS, Straight, Cementless, 14×140mm, Neutral FDA UDI
- Model / Reference
- 3426-11414-0 FDA UDI
- Description
- Stem, PLUS, Straight, Cementless, 14×140mm, Neutral FDA UDI
Identifiers
- Catalog Number
- 3426-11414-0 FDA UDI
- Primary DI / UDI-DI
- 00840286836081 FDA UDI
- FDA Product Code
- JDI FDA UDI
- GMDN Term
- Press-fit hip femur prosthesis, modular 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: Press-fit hip femur prosthesis, modular
UniSyn Hip System by Shalby Advanced Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Press-fit hip femur prosthesis, modular.
- Perfecta — MicroPort Orthopedics Inc. · Class III
- 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
- Profemur — MicroPort Orthopedics Inc. · Class III
- Alloclassic® Zweymüller® — 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 634000e8-93f3-47c2-aece-917c4e1a5013 35 fields · synced May 30, 2026