Identity
- Trade Name
- SMR Shoulder FDA UDI
- Generic Name
- Shoulder glenoid fossa prosthesis trial FDA UDI
- Device Name
- Trial Glenoid 3 Pegs STD FDA UDI
- Model / Reference
- Trial Glenoid 3 Pegs FDA UDI
- Description
- Trial Glenoid 3 Pegs STD FDA UDI
Identifiers
- Catalog Number
- 9013.79.010 FDA UDI
- Primary DI / UDI-DI
- 08033390023573 FDA UDI
- 510(k) Number
- K130642 FDA UDI
- FDA Product Code
- KWS FDA UDI
- GMDN Term
- Shoulder glenoid fossa prosthesis trial 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Shoulder glenoid fossa prosthesis trial
SMR Shoulder by Limacorporate — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Shoulder glenoid fossa prosthesis trial.
- BIO-MODULAR(R) SHOULDER — Biomet Orthopedics, Inc. · Class I
- Tornier Perform — TORNIER, INC. · Class I
- OLYMPIA — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
- Alliance® — Zimmer, Inc. · Class II
- REUNION — Stryker Corp. · Class I
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class I
- Titan Modular Shoulder System 2.5 — Smith & Nephew, Inc. · Class I
- REUNION — Stryker Corp. · Class I
Cleared under the same submission
K130642 also covers:
- GLENOID DRILL MASK WITH CENTRAL PEG FOR 3PEGS — Limacorporate
- GLENOID DRILL MASK WITH CENTRAL PEG FOR 3PEGS — Limacorporate
- GLENOID DRILL MASK WITH CENTRAL PEG FOR 3PEGS — Limacorporate
- GLENOID DRILL MASK WITH CENTRAL PEG FOR 3PEGS — 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 0d852d43-b3b2-4ece-bb8d-de73f0994ef4 36 fields · synced Jun 1, 2026