Identity
- Trade Name
- SMR Shoulder FDA UDI
- Generic Name
- Shoulder humeral body prosthesis FDA UDI
- Device Name
- Finned humeral bodies with locking screw FDA UDI
- Model / Reference
- Humeral Body FDA UDI
- Description
- Finned humeral bodies with locking screw FDA UDI
Identifiers
- Catalog Number
- 1350.15.110 FDA UDI
- Primary DI / UDI-DI
- 08033390002035 FDA UDI
- 510(k) Number
- K101263 FDA UDI
- FDA Product Code
- HSD FDA UDIKWT FDA UDI
- GMDN Term
- Shoulder humeral body 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: Shoulder humeral body prosthesis
SMR Shoulder by Limacorporate — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Shoulder humeral body prosthesis.
- Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG · Class II
- Equinoxe — Exactech, Inc. · Class II
- Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG · Class II
- Anatomical Shoulder™ Domelock® — Zimmer, Inc. · Class II
- HemiCAP® — ARTHROSURFACE INCORPORATED · Class II
- Humeris Shoulder — FX SOLUTIONS · Class II
- OVOMotion™ — ARTHROSURFACE INCORPORATED · Class II
- HemiCAPOVO® — ARTHROSURFACE INCORPORATED · 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 a5511654-dbcd-4f25-bed8-5b24f35fda2e 36 fields · synced May 30, 2026