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Auxein Nailing System

by Auxein Medical Private Limited 2 variants

510(k) K210792

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK210792 Date25 Aug 2021ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
HWC
Device class
Class II
Regulation
21 CFR Part 888.3040
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

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Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • 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.