Identity
- Trade Name
- HemiCAPGRS® FDA UDI
- Generic Name
- Shoulder glenoid fossa prosthesis, prefabricated FDA UDI
- Device Name
- ARTICULAR, 20 X 25MM IMPLANT, GLENOID 53/50 HEAD FDA UDI
- Model / Reference
- G203-2520-W FDA UDI
- Description
- ARTICULAR, 20 X 25MM IMPLANT, GLENOID 53/50 HEAD FDA UDI
Identifiers
- Catalog Number
- G203-2520-W FDA UDI
- Primary DI / UDI-DI
- M528G2032520W0 FDA UDI
- 510(k) Number
- K091196 FDA UDI
- FDA Product Code
- KWS FDA UDI
- GMDN Term
- Shoulder glenoid fossa prosthesis, prefabricated 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: Shoulder glenoid fossa prosthesis, prefabricated
HemiCAPGRS® by Arthrosurface Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K091196 also covers:
- HemiCAPGRS® — ARTHROSURFACE INCORPORATED
- HemiCAPGRS® — ARTHROSURFACE INCORPORATED
- HemiCAPGRS® — ARTHROSURFACE INCORPORATED
- HemiCAPGRS® — ARTHROSURFACE INCORPORATED
- HemiCAPGRS® — ARTHROSURFACE INCORPORATED
- HemiCAPGRS® — ARTHROSURFACE INCORPORATED
- HemiCAPGRS® — ARTHROSURFACE INCORPORATED
- HemiCAPGRS® — ARTHROSURFACE INCORPORATED
- HemiCAPGRS® — ARTHROSURFACE INCORPORATED
- HemiCAPGRS® — ARTHROSURFACE INCORPORATED
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Arthrosurface Incorporated
Sources (1)
- FDA UDI 6bdb7f14-0eb6-4eaf-937c-541f19eb5bd6 36 fields · synced Jun 8, 2026