Identity
- Trade Name
- SMR System FDA UDI
- Generic Name
- Reverse shoulder prosthesis head FDA UDI
- Device Name
- SMR System - Glenosphere Eccentrical Dia. 36 mm FDA UDI
- Model / Reference
- 1376.09.031 FDA UDI
- Description
- SMR System - Glenosphere Eccentrical Dia. 36 mm FDA UDI
Identifiers
- Catalog Number
- 1376.09.031 FDA UDI
- Primary DI / UDI-DI
- 08033390272339 FDA UDI
- 510(k) Number
- K163397 FDA UDI
- FDA Product Code
- KWS FDA UDIKWT FDA UDIMBF FDA UDIPHX FDA UDI
- GMDN Term
- Reverse shoulder prosthesis head FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 FDA UDI888.3650 FDA UDI888.3670 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: Reverse shoulder prosthesis head
SMR System by Limacorporate — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Reverse shoulder prosthesis head.
- Equinoxe — Exactech, Inc. · Class II
- Equinoxe — Exactech, Inc. · Class II
- JARVIS Glenoid Rerverse Shoulder Prosthesis — FOURNITURES HOSPITALIERES INDUSTRIE · Class II
- Trabecular Metal Reverse Plus™ — Zimmer, Inc. · Class II
- AGILON® XO glenosphere neutral incl. screw — implantcast GmbH · Class II
- TORNIER PERFORM™ REVERSED — TORNIER, INC. · Class II
- Titan™ Reverse Shoulder System — Ascension Orthopedics, Inc. · Class II
- Equinoxe — Exactech, Inc. · Class II
Cleared under the same submission
K163397 also covers:
- SMR SYSTEM — 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 11ebd744-8abf-4ab9-8f8b-bc84c589ecbf 36 fields · synced Jun 8, 2026