Identity
- Trade Name
- SMR Shoulder FDA UDI
- Generic Name
- Resurfacing humeral head prosthesis fixation peg FDA UDI
- Device Name
- Resurfacing stems (Ti6Al4V) 11 x 32mm FDA UDI
- Model / Reference
- Stem FDA UDI
- Description
- Resurfacing stems (Ti6Al4V) 11 x 32mm FDA UDI
Identifiers
- Catalog Number
- 1317.15.010 FDA UDI
- Primary DI / UDI-DI
- 08033390001274 FDA UDI
- 510(k) Number
- K112900 FDA UDI
- FDA Product Code
- KWS FDA UDIHSD FDA UDI
- GMDN Term
- Resurfacing humeral head prosthesis fixation peg FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 FDA UDI888.3690 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: Resurfacing humeral head prosthesis fixation peg
SMR Shoulder by Limacorporate — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Resurfacing humeral head prosthesis fixation peg.
- Equinoxe — Exactech, Inc. · Class II
- Equinoxe — Exactech, Inc. · Class II
- SMR Shoulder — Limacorporate · Class II
- SMR System — Limacorporate · Class II
- SMR System — Limacorporate · Class II
Cleared under the same submission
K112900 also covers:
- SMR — Limacorporate
- SMR — Limacorporate
- SMR — Limacorporate
- SMR — Limacorporate
- SMR Resurfacing System — Limacorporate
- SMR Resurfacing System — Limacorporate
- SMR Resurfacing System — Limacorporate
- SMR Resurfacing System — Limacorporate
- SMR Resurfacing System — Limacorporate
- SMR Resurfacing System — Limacorporate
- SMR Resurfacing System — Limacorporate
- SMR Resurfacing System — 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 |
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Manufacturer
- Manufacturer
- Limacorporate
Sources (1)
- FDA UDI bd0f86d8-771c-4458-9dfe-a40edea2a45d 36 fields · synced May 31, 2026