Identity
- Trade Name
- Dynamic Axial Fixator FDA UDI
- Generic Name
- Fluted surgical drill bit, single-use FDA UDI
- Device Name
- CANNULATED DRILL BIT D.3,2 MM L.200 MM TIN COATED - QUICK CONNECT STERILE FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- CANNULATED DRILL BIT D.3,2 MM L.200 MM TIN COATED - QUICK CONNECT STERILE FDA UDI
Identifiers
- Catalog Number
- 99-1-1101101 FDA UDI
- Primary DI / UDI-DI
- 18033509856006 FDA UDI
- 510(k) Number
- K955848 FDA UDI
- FDA Product Code
- JDW FDA UDI
- GMDN Term
- Fluted surgical drill bit, single-use 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 200 Millimeter FDA UDIOuter Diameter — 3.2 Millimeter FDA UDI
Category: Fluted surgical drill bit, single-use
Dynamic Axial Fixator by Orthofix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K955848 also covers:
- ADULT LIMB RECONSTRUCTION SYSTEM — Orthofix, Inc.
- ADULT LIMB RECONSTRUCTION SYSTEM — Orthofix, Inc.
- ADULT LIMB RECONSTRUCTION SYSTEM — Orthofix, Inc.
- ADVANCED LIMB RECONSTRUCTION SYSTEM — Orthofix, Inc.
- Bone Screws — Orthofix, Inc.
- Bone Screws — Orthofix, Inc.
- Bone Screws — Orthofix, Inc.
- Bone Screws — Orthofix, Inc.
- Bone Screws — Orthofix, Inc.
- Bone Screws — Orthofix, Inc.
- Bone Screws — Orthofix, Inc.
- Bone Screws — Orthofix, Inc.
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
- Orthofix, Inc.
Sources (1)
- FDA UDI 2a093975-412b-4864-9e1a-ab41bc8bc9b8 37 fields · synced Jun 1, 2026