Identity
- Trade Name
- SMR Shoulder FDA UDI
- Generic Name
- Coated shoulder humeral stem prosthesis FDA UDI
- Device Name
- Humeral Head (CoCrMo) - Dia.40mm H.13 Ecc.2 FDA UDI
- Model / Reference
- Humeral Head (CoCrMo) FDA UDI
- Description
- Humeral Head (CoCrMo) - Dia.40mm H.13 Ecc.2 FDA UDI
Identifiers
- Catalog Number
- 1321.09.402 FDA UDI
- Primary DI / UDI-DI
- 08033390116176 FDA UDI
- 510(k) Number
- K161476 FDA UDI
- FDA Product Code
- KWT FDA UDIHSD FDA UDI
- GMDN Term
- Coated shoulder humeral stem 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: Coated shoulder humeral stem prosthesis
SMR Shoulder by Limacorporate — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coated shoulder humeral stem prosthesis.
- OsseoFit™ Stemless Shoulder — Zimmer, Inc. · Class II
- TORNIER PERFORM™ HUMERAL SYSTEM — TORNIER, INC. · Class II
- Tornier HRS — TORNIER, INC. · Class II
- Comprehensive® Shoulder System — Biomet Orthopedics, Inc. · Class II
- Trabecular Metal® — Zimmer, Inc. · Class II
- Comprehensive SRS — Biomet Orthopedics, Inc. · Class II
- INHANCE — DEPUY (IRELAND) · Class II
- Aequalis™ PerFORM+ — TORNIER, INC. · Class II
Cleared under the same submission
K161476 also covers:
- 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
- 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 823be14b-712d-4479-8cc6-e8f09f62637d 36 fields · synced May 31, 2026