Identity
- Trade Name
- OIC Cannulated Screw System FDA UDI
- Generic Name
- Surgical instrument handle, non-torque-limiting FDA UDI
- Device Name
- QUICK CONNECT AO SMALL WOOD HANDLE FDA UDI
- Model / Reference
- 01-4006 FDA UDI
- Description
- QUICK CONNECT AO SMALL WOOD HANDLE FDA UDI
Identifiers
- Primary DI / UDI-DI
- M6960140060 FDA UDI
- 510(k) Number
- K113123 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Surgical instrument handle, non-torque-limiting FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical instrument handle, non-torque-limiting
OIC Cannulated Screw System by Orthopaedic Implant Company, The — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K113123 also covers:
- OIC Cannulated Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Cannulated Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Cannulated Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Cannulated Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Cannulated Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Cannulated Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Cannulated Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Cannulated Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Cannulated Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Cannulated Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Cannulated Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Cannulated Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE
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
- Orthopaedic Implant Company, The
Sources (1)
- FDA UDI f1e8b3a8-c572-4ebe-a471-a2b737cc6cca 35 fields · synced Jun 1, 2026