Identity
- Trade Name
- SMR System FDA UDI
- Generic Name
- Metallic reverse shoulder prosthesis cup FDA UDI
- Device Name
- SMR System - Reverse HP Liner Long Dia. 40mm FDA UDI
- Model / Reference
- 1365.09.020 FDA UDI
- Description
- SMR System - Reverse HP Liner Long Dia. 40mm FDA UDI
Identifiers
- Catalog Number
- 1365.09.020 FDA UDI
- Primary DI / UDI-DI
- 08033390061292 FDA UDI
- 510(k) Number
- K243826 FDA UDI
- FDA Product Code
- PHX FDA UDI
- GMDN Term
- Metallic 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: Metallic 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 Metallic reverse shoulder prosthesis cup.
- Arthrex® — Arthrex, Inc. · Class II
- Anatomical Shoulder™ — Zimmer, Inc. · Class II
- Arthrex® — Arthrex, Inc. · Class II
- REUNION — Stryker Corp. · Class II
- Arthrex® — Arthrex, Inc. · Class II
- Arthrex® — Arthrex, Inc. · Class II
- Arthrex® — Arthrex, Inc. · Class II
- REUNION — Stryker Corp. · Class II
Cleared under the same submission
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 2f35217d-70e0-40a2-81ec-3f5fcf55d998 36 fields · synced May 30, 2026