Identity
- Trade Name
- RetroFix FDA UDI
- Generic Name
- Orthopaedic bone wire FDA UDI
- Device Name
- Surgical K-Wire Kirshner wire or pins Guide Wire 1.3mm Diameter 300 mm Length FDA UDI
- Model / Reference
- K-Wire, 1.3mm x 300mm PK 25 FDA UDI
- Description
- Surgical K-Wire Kirshner wire or pins Guide Wire 1.3mm Diameter 300 mm Length FDA UDI
Identifiers
- Catalog Number
- CTM001055 FDA UDI
- Primary DI / UDI-DI
- 00850005757658 FDA UDI
- 510(k) Number
- K200226 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic bone wire 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic bone wire
RetroFix by Retrofix Screws, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic bone wire.
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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 dd8e1d07-f1cf-4553-97ba-7c7e7a7d359b 36 fields · synced Jun 6, 2026