Identity
- Trade Name
- Humeral Cup Stability FDA UDI
- Generic Name
- Polyethylene reverse shoulder prosthesis cup FDA UDI
- Device Name
- HUMERAL CUP STABILITY PE/TA6V Ø32/+3 FDA UDI
- Model / Reference
- 102-1003 FDA UDI
- Description
- HUMERAL CUP STABILITY PE/TA6V Ø32/+3 FDA UDI
Identifiers
- Catalog Number
- 102-1003 FDA UDI
- Primary DI / UDI-DI
- 03701037309384 FDA UDI
- FDA Product Code
- PHX FDA UDI
- GMDN Term
- Polyethylene reverse shoulder prosthesis cup FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 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
No
FDA UDI
Category: Polyethylene reverse shoulder prosthesis cup
Humeral Cup Stability by Fx Solutions — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polyethylene reverse shoulder prosthesis cup.
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- PERFORM™ HUMERAL SYSTEM — TORNIER, INC. · Class II
- SMR System — Limacorporate · 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
- Fx Solutions
Sources (1)
- FDA UDI 86e9fe16-edfb-49dd-9808-27166c2eafd5 35 fields · synced May 30, 2026