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Synthes Synmesh

by Synthes (Usa) 510(k)

Active United States

510(k) K983766

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK983766 Date18 Dec 1998ClearedStatusActive

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

14 recalls · FDA

  • 14 recalls, same reason

    • Terminated Z-0404-2021 FDA Class III initiated 21 Sep 2020 via K983766, on the same 510(k)
    • Terminated Z-0405-2021 FDA Class III initiated 21 Sep 2020 via K983766, on the same 510(k)
    • Terminated Z-0411-2021 FDA Class III initiated 21 Sep 2020 via K983766, on the same 510(k)
    • Terminated Z-0415-2021 FDA Class III initiated 21 Sep 2020 via K983766, on the same 510(k)
    • Terminated Z-0410-2021 FDA Class III initiated 21 Sep 2020 via K983766, on the same 510(k)
    • Terminated Z-0408-2021 FDA Class III initiated 21 Sep 2020 via K983766, on the same 510(k)
    • Terminated Z-0416-2021 FDA Class III initiated 21 Sep 2020 via K983766, on the same 510(k)
    • Terminated Z-0403-2021 FDA Class III initiated 21 Sep 2020 via K983766, on the same 510(k)
    • Terminated Z-0407-2021 FDA Class III initiated 21 Sep 2020 via K983766, on the same 510(k)
    • Terminated Z-0409-2021 FDA Class III initiated 21 Sep 2020 via K983766, on the same 510(k)
    • Terminated Z-0413-2021 FDA Class III initiated 21 Sep 2020 via K983766, on the same 510(k)
    • Terminated Z-0406-2021 FDA Class III initiated 21 Sep 2020 via K983766, on the same 510(k)
    • Terminated Z-0412-2021 FDA Class III initiated 21 Sep 2020 via K983766, on the same 510(k)
    • Terminated Z-0414-2021 FDA Class III initiated 21 Sep 2020 via K983766, on the same 510(k)

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

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

510(k)

510(k) Number
FDA Product Code
EZX
Device Class
Class II
Regulation
21 CFR Part 878.3300
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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