Identity
- Trade Name
- SMR Shoulder FDA UDI
- Generic Name
- Orthopaedic implant/instrument dismantling device FDA UDI
- Device Name
- Pliers for Trial Adaptor FDA UDI
- Model / Reference
- Pliers for Trial Adaptor FDA UDI
- Description
- Pliers for Trial Adaptor FDA UDI
Identifiers
- Catalog Number
- 9013.30.100 FDA UDI
- Primary DI / UDI-DI
- 08033390038836 FDA UDI
- 510(k) Number
- K100858 FDA UDI
- FDA Product Code
- KWT FDA UDIHSD FDA UDI
- GMDN Term
- Orthopaedic implant/instrument dismantling device 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
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: Orthopaedic implant/instrument dismantling device
SMR Shoulder by Limacorporate — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic implant/instrument dismantling device.
- TLX — Nuvasive, Inc. · Class I
- CHARLOTTE — WRIGHT MEDICAL TECHNOLOGY, INC. · Class I
- Omnia Medical VBR — Omnia Medical · Class I
- ReLine — Nuvasive, Inc. · Class I
- Tornier Perform — TORNIER, INC. · Class I
- CANCELLO-PURE — WRIGHT MEDICAL TECHNOLOGY, INC. · Class I
- Avenue T — Ldr Spine USA · Class I
- OSS™ — Biomet Orthopedics, Inc. · Class I
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 653280e1-2bd2-40af-929b-d5ebac421ff6 35 fields · synced Jun 8, 2026