Identity
- Trade Name
- SMR Shoulder FDA UDI
- Generic Name
- Stem-fixed metallic humeral head prosthesis FDA UDI
- Device Name
- Eccentrical adaptor tapers +2mm, Standard FDA UDI
- Model / Reference
- Eccentrical Adaptor FDA UDI
- Description
- Eccentrical adaptor tapers +2mm, Standard FDA UDI
Identifiers
- Catalog Number
- 1330.15.272 FDA UDI
- Primary DI / UDI-DI
- 08033390001922 FDA UDI
- 510(k) Number
- K100858 FDA UDI
- FDA Product Code
- KWT FDA UDIHSD FDA UDI
- GMDN Term
- Stem-fixed metallic humeral head prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3650 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: Stem-fixed metallic humeral head prosthesis
SMR Shoulder by Limacorporate — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Stem-fixed metallic humeral head prosthesis.
- MRS — Howmedica Osteonics Corp. · Class II
- FLEX SHOULDER SYSTEM — TORNIER, INC. · Class II
- FLEX SHOULDER SYSTEM — TORNIER, INC. · Class II
- GLOBAL ADVANTAGE — DEPUY ORTHOPAEDICS, INC. · Class II
- FLEX SHOULDER SYSTEM — TORNIER, INC. · Class II
- PERFORM™ HUMERAL SYSTEM — TORNIER, INC. · Class II
- Equinoxe — Exactech, Inc. · Class II
- TORNIER PERFORM™ HUMERAL SYSTEM — TORNIER, INC. · Class II
Cleared under the same submission
K100858 also covers:
- GLENOID REAMER WITH CANNULATED PIN — Limacorporate
- GLENOID REAMER WITH CANNULATED PIN — Limacorporate
- Instrument Set — 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 2d5931be-e9a0-443b-83cc-547f758dcf85 36 fields · synced Jun 8, 2026