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Modification to:latarjet Cortical Screw Set, Models 523JT, 523J (36-48mm)

by Tag Medical Products

510(k) K091694

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 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 · Special NumberK091694 Date7 Jul 2009ClearedStatusActive

Recalls

5 recalls · FDA

  • 5 recalls, same reason

    • Terminated Z-2619-2017 FDA Class II initiated 12 May 2017
    • Terminated Z-2616-2017 FDA Class II initiated 12 May 2017
    • Terminated Z-2618-2017 FDA Class II initiated 12 May 2017
    • Terminated Z-2615-2017 FDA Class II initiated 12 May 2017
    • Terminated Z-2617-2017 FDA Class II initiated 12 May 2017

    Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw

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  • Withdrawn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
HWC
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from Tag Medical Products