Identity
- Trade Name
- SMR Metal Back FDA UDI
- Generic Name
- Shoulder glenoid fossa prosthesis, prefabricated FDA UDI
- Device Name
- Metal-back (Ti6Al4V + PoroTi) Small FDA UDI
- Model / Reference
- Uncemented Glenoid FDA UDI
- Description
- Metal-back (Ti6Al4V + PoroTi) Small FDA UDI
Identifiers
- Catalog Number
- 1375.21.020 FDA UDI
- Primary DI / UDI-DI
- 08033390080460 FDA UDI
- 510(k) Number
- K113254 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
SMR Metal Back by Limacorporate — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Shoulder glenoid fossa prosthesis, prefabricated.
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- Titan™ Total Shoulder System — Ascension Orthopedics, Inc. · Class II
Cleared under the same submission
K113254 also covers:
- SMR Metal Back — Limacorporate
- SMR Metal Back — Limacorporate
- SMR Metal Back — Limacorporate
- SMR Shoulder — Limacorporate
- SMR Shoulder — Limacorporate
- SMR Shoulder — Limacorporate
- SMR Shoulder — Limacorporate
- SMR System — Limacorporate
- SMR System — Limacorporate
- SMR System — Limacorporate
- SMR System — Limacorporate
- SMR System — Limacorporate
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
- Limacorporate
Sources (1)
- FDA UDI 3d4b552a-dced-40fa-8512-7b7e70ac712f 36 fields · synced May 30, 2026