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Stryker Surgical Instruments and Accessories

by Stryker Corp.

510(k) K943323

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

10 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 NumberK943323 Date28 Nov 1994ClearedStatusActive

Recalls

10 recalls · FDA

  • 10 recalls, same reason

    • Terminated Z-1027-2009 FDA Unclassified (pre-2012) initiated 10 Oct 2008 on shared 510(k) K943323
    • Terminated Z-1022-2009 FDA Unclassified (pre-2012) initiated 10 Oct 2008 on shared 510(k) K943323
    • Terminated Z-1028-2009 FDA Unclassified (pre-2012) initiated 10 Oct 2008 on shared 510(k) K943323
    • Terminated Z-1023-2009 FDA Unclassified (pre-2012) initiated 10 Oct 2008 on shared 510(k) K943323
    • Terminated Z-1021-2009 FDA Unclassified (pre-2012) initiated 10 Oct 2008 on shared 510(k) K943323
    • Terminated Z-1026-2009 FDA Unclassified (pre-2012) initiated 10 Oct 2008 on shared 510(k) K943323
    • Terminated Z-1029-2009 FDA Unclassified (pre-2012) initiated 10 Oct 2008 on shared 510(k) K943323
    • Terminated Z-1024-2009 FDA Unclassified (pre-2012) initiated 10 Oct 2008 on shared 510(k) K943323
    • Terminated Z-1025-2009 FDA Unclassified (pre-2012) initiated 10 Oct 2008 on shared 510(k) K943323
    • Terminated Z-1030-2009 FDA Unclassified (pre-2012) initiated 10 Oct 2008 on shared 510(k) K943323

    The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
HRX
Device Class
Class II
Regulation
21 CFR Part 888.1100
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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