Identity
- Trade Name
- SMR Shoulder FDA UDI
- Generic Name
- Press-fit shoulder humeral stem prosthesis FDA UDI
- Device Name
- Finned humeral stems - 80mm (Ti6Al4V) dia.19mm FDA UDI
- Model / Reference
- Finned Stem FDA UDI
- Description
- Finned humeral stems - 80mm (Ti6Al4V) dia.19mm FDA UDI
Identifiers
- Catalog Number
- 1304.15.190 FDA UDI
- Primary DI / UDI-DI
- 08033390000932 FDA UDI
- 510(k) Number
- K101263 FDA UDI
- FDA Product Code
- HSD FDA UDIKWT FDA UDI
- GMDN Term
- Press-fit shoulder humeral stem prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3690 FDA UDI888.3650 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: Press-fit shoulder humeral stem prosthesis
SMR Shoulder by Limacorporate — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Press-fit shoulder humeral stem prosthesis.
- Shoulder Innovations Humeral Stemless System — SHOULDER INNOVATIONS, Inc · Class II
- GLOBAL AP — DEPUY ORTHOPAEDICS, INC. · Class II
- GLOBAL ADVANTAGE — DEPUY ORTHOPAEDICS, INC. · Class II
- GLOBAL AP — DEPUY ORTHOPAEDICS, INC. · Class II
- BIO-MODULAR SHOULDER SYSTEM — Biomet Orthopedics, Inc. · Class II
- GLOBAL AP — DEPUY ORTHOPAEDICS, INC. · Class II
- Equinoxe — Exactech, Inc. · Class II
- Shoulder Innovations InSet Humeral Stemless — SHOULDER INNOVATIONS, Inc · Class II
Cleared under the same submission
K101263 also covers:
- SMR Shoulder — Limacorporate
- SMR Shoulder — Limacorporate
- SMR Shoulder — Limacorporate
- SMR Shoulder — Limacorporate
- SMR Shoulder — Limacorporate
- SMR Shoulder — Limacorporate
- SMR Shoulder — Limacorporate
- SMR Shoulder — Limacorporate
- SMR Shoulder — Limacorporate
- SMR Shoulder — Limacorporate
- SMR Shoulder — Limacorporate
- SMR Shoulder — 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 4f01d7c9-1198-406e-82b3-5149e6970882 36 fields · synced Jun 8, 2026