Skip to content

Synthes Usa Hybrid External Fixator Modifications

by Synthes (Usa)

510(k) K073135

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 · Traditional NumberK073135 Date29 Jan 2008ClearedStatusActive

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  • Withdrawn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
LXT
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Synthes Usa Hybrid External Fixator Modifications is an orthopedic appliance, fixation, nail/blade/plate combination, multiple component, metal composite device. It is part of the Synthes Hybrid External Fixator system, which is used for fixation of proximal and/or distal tibial fractures, with or without extension into the tibial shaft.

The device is supplied with various components and is regulated under the product code LXT, with a regulation number of 888.3030. It has been cleared by the FDA under the traditional clearance type, with a decision code of SESE. The device is intended for use in orthopedic applications, specifically for the fixation of tibial fractures.

Other devices from Synthes (Usa)

See all devices from Synthes (Usa) →

Questions

AI-generated answers, 21 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 Synthes Hybrid External Fixator Modifications used for?

    The Synthes Hybrid External Fixator Modifications is used for fixation of proximal and/or distal tibial fractures, with or without extension into the tibial shaft, as part of the Synthes Hybrid External Fixator system, which is an orthopedic appliance.

  • What type of device is the Synthes Hybrid External Fixator Modifications?

    The Synthes Hybrid External Fixator Modifications is a metal composite device, classified as an orthopedic appliance, fixation, nail/blade/plate combination, multiple component.

  • How is the Synthes Hybrid External Fixator Modifications supplied?

    The device is supplied with various components as part of the Synthes Hybrid External Fixator system.

  • What is the regulatory classification of the Synthes Hybrid External Fixator Modifications?

    The device is regulated under the product code LXT, with a regulation number of 888.3030, and has been cleared by the FDA under the traditional clearance type.