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Contoured Articular Prosthesis (Cap) Humeral Head Resurfacing System

by Std Mfg., Inc.

510(k) K023096

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 · Traditional NumberK023096 Date10 Apr 2003ClearedStatusActive

Recalls

5 recalls · FDA

  • 5 recalls, same reason

    • Terminated Z-1114-2015 FDA Class II initiated 24 Nov 2014
    • Terminated Z-1112-2015 FDA Class II initiated 24 Nov 2014
    • Terminated Z-1113-2015 FDA Class II initiated 24 Nov 2014
    • Terminated Z-1111-2015 FDA Class II initiated 24 Nov 2014
    • Terminated Z-1110-2015 FDA Class II initiated 24 Nov 2014

    Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.

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  • Withdrawn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
HSD
Device Class
Class II
Regulation
21 CFR Part 888.3690
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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