← Back to catalogue
SMR Shoulder
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 1304.15.017Model SMR SHOULDER
Identity
- Trade Name
- SMR SHOULDER - FINNED STEM - SHORT DIA.17 MM EUDAMEDSMR Shoulder FDA UDI
- Generic Name
- Press-fit shoulder humeral stem prosthesis FDA UDI
- Device Name
- Finned Stem SHORT Dia. 17 mm FDA UDI
- Model / Reference
- 1304.15.017 EUDAMEDFDA UDISMR SHOULDER EUDAMED
- Description
- Finned Stem SHORT Dia. 17 mm FDA UDI
Identifiers
- Catalog Number
- 1304.15.017 FDA UDI
- Primary DI / UDI-DI
- 08033390155328 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08033390155328 EUDAMED
- 510(k) Number
- K191963 FDA UDI
- FDA Product Code
- KWS FDA UDIMBF FDA UDIHSD FDA UDIPHX FDA UDIKWT FDA UDI
- EMDN Code
- P0901040202 SHOULDER PROSTHESES MODULAR STEMS EUDAMED
- GMDN Term
- Press-fit shoulder humeral stem prosthesis FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3660 FDA UDI888.3670 FDA UDI888.3690 FDA UDI888.3650 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — 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
K191963 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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| 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 (2)
- FDA UDI 3a0cc0bb-b0c0-48ac-b966-1ba2c7df87c6 36 fields · synced Jun 19, 2026
- EUDAMED 278f0b8b-c621-4df7-b6dc-b5f071bccd69 61 fields · synced Jun 19, 2026