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Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0

by Normed Medizin-Technik GmbH

510(k) K123347

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

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 NumberK123347 Date2 Aug 2013ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1451-2019 FDA Class II initiated 8 Apr 2019 on shared 510(k) K123347
    • Terminated Z-1433-2019 FDA Class II initiated 8 Apr 2019 on shared 510(k) K123347

    An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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

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