Identity
- Trade Name
- SMR System FDA UDI
- Generic Name
- Polyethylene reverse shoulder prosthesis cup FDA UDI
- Device Name
- SMR System - Retentive Liner +3mm FDA UDI
- Model / Reference
- 1361.50.815 FDA UDI
- Description
- SMR System - Retentive Liner +3mm FDA UDI
Identifiers
- Catalog Number
- 1361.50.815 FDA UDI
- Primary DI / UDI-DI
- 08033390273633 FDA UDI
- 510(k) Number
- K110598 FDA UDI
- FDA Product Code
- PHX FDA UDIKWS FDA UDI
- GMDN Term
- Polyethylene reverse shoulder prosthesis cup 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: Polyethylene reverse shoulder prosthesis cup
SMR System by Limacorporate — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polyethylene reverse shoulder prosthesis cup.
- PERFORM™ HUMERAL SYSTEM — TORNIER, INC. · Class II
- PERFORM™ HUMERAL SYSTEM — TORNIER, INC. · Class II
- PERFORM™ HUMERAL SYSTEM — TORNIER, INC. · Class II
- FX V135 Shoulder Prosthesis — FX SOLUTIONS · Class II
- TORNIER PERFORM™ HUMERAL SYSTEM — TORNIER, INC. · Class II
- Equinoxe® — Exactech, Inc. · Class II
- Tornier Perform Humeral System — TORNIER, INC. · Class II
- PERFORM™ HUMERAL SYSTEM — TORNIER, INC. · Class II
Cleared under the same submission
K110598 also covers:
- Guide Screw for Trial Glenosphere — Limacorporate
- Guide Screw for Trial Glenosphere — Limacorporate
- ProMade — Limacorporate
- SMR Metal Back — Limacorporate
- 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 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 13ed672b-fe3c-43a9-ab16-a4525a6050af 36 fields · synced Jun 8, 2026