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MectaLIF Anterior Extension

by Medacta International S.A.

510(k) K221545

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

6 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 NumberK221545 Date24 Oct 2022ClearedStatusActive

Recalls

6 recalls · FDA

  • 6 recalls, same reason

    • Completed Z-1400-2023 FDA Class II initiated 8 Mar 2023
    • Completed Z-1402-2023 FDA Class II initiated 8 Mar 2023
    • Completed Z-1405-2023 FDA Class II initiated 8 Mar 2023
    • Completed Z-1404-2023 FDA Class II initiated 8 Mar 2023
    • Completed Z-1401-2023 FDA Class II initiated 8 Mar 2023
    • Completed Z-1403-2023 FDA Class II initiated 8 Mar 2023

    There is a potential for breakage of the small screw used to affix the anti-backout plate.

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  • Withdrawn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
OVD
Device Class
Class II
Regulation
21 CFR Part 888.3080
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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