Identifiers
- 510(k) Number
- K210792 FDA 510(k)
- FDA Product Code
- HWC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3040 FDA 510(k)
- Regulation Number
- 888.3040 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Auxein Nailing System is an intramedullary nailing system, also known as an intramedullary rod or inter-locking nail, designed to restore the fractured bone to its pre-injured state. It is used to replicate the natural shape of long bones in the human skeleton. The system is specifically designed for orthopedic use. It utilizes a technology to ensure a solid interface between the nail and bone.
The Auxein Nailing System is supplied with a product code of HWC and is classified as a class 2 device. It has received FDA 510K authorization. The system is designed for use in orthopedic applications and is intended to provide stabilization and support for fractured bones. The device is available with a clearance type of Special.
Frequently asked questions
What is the Auxein Nailing System used for?
The Auxein Nailing System is used to restore fractured bones to their pre-injured state, providing stabilization and support for orthopedic applications.
What type of device is the Auxein Nailing System?
The Auxein Nailing System is a class 2 device, specifically an intramedullary nailing system, also known as an intramedullary rod or inter-locking nail.
What is the regulatory status of the Auxein Nailing System?
The Auxein Nailing System has received FDA 510K authorization, indicating that it is substantially equivalent to a predicate device.
How is the Auxein Nailing System supplied?
The Auxein Nailing System is supplied with a product code of HWC, and its clearance type is Special.
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. Sources consulted: Nailing System - Auxein: Pioneering Orthopedic Solutions Worldwide, Auxein Nailing System 510 (k) K192003 - FDA.report, Auxein Medical | LinkedIn
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K210792 | Class II | Active |
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Manufacturer
- Manufacturer
- Auxein Medical Private Limited
Sources (1)
- FDA 510(k) K210792 24 fields · synced Sep 22, 2026