Identity
- Trade Name
- SMR System FDA UDI
- Generic Name
- Humeral head spacer FDA UDI
- Device Name
- SMR System - Adaptor Taper Eccentrical 2mm Long FDA UDI
- Model / Reference
- 1331.15.272 FDA UDI
- Description
- SMR System - Adaptor Taper Eccentrical 2mm Long FDA UDI
Identifiers
- Catalog Number
- 1331.15.272 FDA UDI
- Primary DI / UDI-DI
- 08033390272100 FDA UDI
- 510(k) Number
- K100858 FDA UDI
- FDA Product Code
- KWT FDA UDIHSD FDA UDI
- GMDN Term
- Humeral head spacer 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: Humeral head spacer
SMR System by Limacorporate — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Humeral head spacer.
- LINK Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG · Class II
- Aequalis™ Adjustable Reversed — TORNIER, INC. · Class II
- Aequalis™ Adjustable Reversed — TORNIER, INC. · Class II
- Aequalis™ Adjustable Reversed — TORNIER, INC. · Class II
- Aequalis™ Adjustable Reversed — TORNIER, INC. · Class II
- Aequalis™ Adjustable Reversed — TORNIER, INC. · Class II
- LINK Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG · Class II
- Aequalis™ Adjustable Reversed — 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 b4e0f3ba-437d-499a-8713-b3ab1400aa6d 36 fields · synced May 30, 2026