Identity
- Trade Name
- FO Micro Screw System FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- 2.0 FO Guide Sleeve FDA UDI
- Model / Reference
- CPN000052 FDA UDI
- Description
- 2.0 FO Guide Sleeve FDA UDI
Identifiers
- Catalog Number
- BTSC00043 FDA UDI
- Primary DI / UDI-DI
- 09353903002666 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Surgical drill guide, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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: Surgical drill guide, reusable
The FO Micro Screw System is a reliable and efficient surgical drill guide designed for orthopedic procedures. Made from durable metal, this device allows surgeons to accurately place and angle the rotating surgical drill on hard tissue surfaces, providing a secure grip during complex surgeries.
Similar devices
Also classified as Surgical drill guide, reusable.
- ORTHOFIX — Orthofix, Inc. · Class I
- Titan™ — Ascension Orthopedics, Inc. · Class I
- Medtronic Resuable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- Distal Elbow Plating System — SKELETAL DYNAMICS L.L.C. · Class II
- Truliant — Exactech, Inc. · Class II
- Vantage — Exactech, Inc. · Class II
- Legion — Smith & Nephew, Inc. · Class II
- Hintermann Series — Dt Medtech, LLC · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Field Orthopaedics Pty Ltd
Sources (1)
- FDA UDI 6c8566b5-9a4c-4956-addd-3b4f5b0c7760 34 fields · synced Jul 24, 2026