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Integra External Fixation System

by Ascension Orthopedic 510(k)

Active United States

510(k) K140463

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK140463 Date10 Oct 2014ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

3 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2387-2016 FDA Class II initiated 20 Jul 2016
    • Terminated Z-2386-2016 FDA Class II initiated 20 Jul 2016

    Through the investigation of reported complaints Integra verified that there have been instances where the Universal Wire Fixation Bolts the Slotted Post broke during use at the surgical site.

    • Terminated Z-2296-2016 FDA Class II initiated 1 Jul 2016

    The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold.

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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