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Synthes Synmesh Spacer System

by Synthes (Usa)

510(k) K003275

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

14 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 NumberK003275 Date23 Apr 2001ClearedStatusActive

Recalls

14 recalls · FDA

  • 14 recalls, same reason

    • Terminated Z-0404-2021 FDA Class III initiated 21 Sep 2020
    • Terminated Z-0405-2021 FDA Class III initiated 21 Sep 2020
    • Terminated Z-0411-2021 FDA Class III initiated 21 Sep 2020
    • Terminated Z-0415-2021 FDA Class III initiated 21 Sep 2020
    • Terminated Z-0410-2021 FDA Class III initiated 21 Sep 2020
    • Terminated Z-0408-2021 FDA Class III initiated 21 Sep 2020
    • Terminated Z-0416-2021 FDA Class III initiated 21 Sep 2020
    • Terminated Z-0403-2021 FDA Class III initiated 21 Sep 2020
    • Terminated Z-0407-2021 FDA Class III initiated 21 Sep 2020
    • Terminated Z-0409-2021 FDA Class III initiated 21 Sep 2020
    • Terminated Z-0413-2021 FDA Class III initiated 21 Sep 2020
    • Terminated Z-0406-2021 FDA Class III initiated 21 Sep 2020
    • Terminated Z-0412-2021 FDA Class III initiated 21 Sep 2020
    • Terminated Z-0414-2021 FDA Class III initiated 21 Sep 2020

    Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"

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  • Withdrawn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
MQP
Device Class
Class II
Regulation
21 CFR Part 888.3060
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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