Identity
- Trade Name
- RetroFix FDA UDI
- Generic Name
- Cannulated surgical drill bit, reusable FDA UDI
- Device Name
- Cannulated Drill Bit 4mm X 180mm Quick Connect Cannulated for a 1.3mm K-Wire (Kirshner Wire) FDA UDI
- Model / Reference
- Drill, 4mm x 180mm, cannulated FDA UDI
- Description
- Cannulated Drill Bit 4mm X 180mm Quick Connect Cannulated for a 1.3mm K-Wire (Kirshner Wire) FDA UDI
Identifiers
- Catalog Number
- CTM000884 FDA UDI
- Primary DI / UDI-DI
- 00850005757696 FDA UDI
- 510(k) Number
- K200226 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Cannulated surgical drill bit, reusable 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: Cannulated surgical drill bit, reusable
RetroFix by Retrofix Screws, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cannulated surgical drill bit, reusable.
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Cleared under the same submission
K200226 also covers:
- RetroFix — RETROFIX SCREWS, LLC
- RetroFix — RETROFIX SCREWS, LLC
- RetroFix — RETROFIX SCREWS, LLC
- RetroFix — RETROFIX SCREWS, LLC
- RetroFix — RETROFIX SCREWS, LLC
- RetroFix — RETROFIX SCREWS, LLC
- RetroFix — RETROFIX SCREWS, LLC
- RetroFix — RETROFIX SCREWS, LLC
- RetroFix — RETROFIX SCREWS, LLC
- RetroFix — RETROFIX SCREWS, LLC
- RetroFix — RETROFIX SCREWS, LLC
- RetroFix — RETROFIX SCREWS, LLC
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
- Retrofix Screws, Llc
Sources (1)
- FDA UDI 9d59f4ab-63e3-4a43-80b9-36cf95594574 36 fields · synced May 30, 2026