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Salvation External Fixation System

by Wrightmedicaltechnologyinc 510(k)

Active United States

510(k) K180832

Overview

The Salvation External Fixation System is an orthopedic external fixation device designed to address fractures, nonunion, and complex foot and ankle deformities including Charcot neuroarthropathy. It is intended for use as a standalone fixation device or in conjunction with the Salvation Beams and Bolts or the Salvation 3Di Plating System.

The system is supplied non-sterile and is intended for single-use. It is manufactured by Wright Medical Technology, Inc. and has received FDA 510(k) clearance under K-number K180832. The device is regulated as a Class II medical device with product code KTT and was cleared on June 6, 2018, following a special 510(k) submission process.

AI-generated from registry data, 22 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK180832 Date6 Jun 2018ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KTT
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Salvation External Fixation System used for?

    The Salvation External Fixation System is designed to address fractures, nonunion, and complex foot and ankle deformities including Charcot neuroarthropathy. It can be used as a standalone fixation device or in conjunction with the Salvation Beams and Bolts or the Salvation 3Di Plating System to provide stabilization in orthopedic trauma and reconstructive procedures.

  • How is the Salvation External Fixation System supplied and is it reusable?

    The system is supplied non-sterile and is intended for single-use only. This means it must be sterilized by the healthcare provider before use and should not be reprocessed or reused after a procedure to ensure patient safety and device integrity.

  • What regulatory clearance does the Salvation External Fixation System have?

    The Salvation External Fixation System has received FDA 510(k) clearance under K-number K180832. It was cleared on June 6, 2018, following a special 510(k) submission process and is regulated as a Class II medical device with product code KTT.