Auxein's DHS/DCS Plate System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K221787 FDA 510(k)
- FDA Product Code
- KTT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Auxein's DHS/DCS Plate System is an orthopedic device used for fracture fixation. It is designed to provide stabilization for fractures in the femur, specifically in the area of the femoral neck and intertrochanteric region.
The system is supplied as a sterile, single-use device and is available in various sizes to accommodate different anatomical requirements. It is intended for use in surgical settings and has received FDA 510(k) clearance with the product code KTT.
Frequently asked questions
What is the Auxein's DHS/DCS Plate System used for?
The Auxein's DHS/DCS Plate System is an orthopedic device designed for fracture fixation, specifically providing stabilization for fractures in the femur, particularly in the femoral neck and intertrochanteric region.
How is the Auxein's DHS/DCS Plate System supplied?
The system is supplied as a sterile, single-use device and is available in various sizes to accommodate different anatomical requirements, intended for use in surgical settings.
What regulatory clearance has the Auxein's DHS/DCS Plate System received?
The Auxein's DHS/DCS Plate System has received FDA 510(k) clearance with the product code KTT, classified under the orthopedic advisory committee.
Is the Auxein's DHS/DCS Plate System reusable?
No, the Auxein's DHS/DCS Plate System is supplied as a sterile, single-use device and should not be reused for patient safety and regulatory compliance reasons.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K221787 | Class II | Active |
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Manufacturer
- Manufacturer
- Auxein Medical Private Limited
Sources (1)
- FDA 510(k) K221787 24 fields · synced Sep 23, 2026