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Spiralok Anchor

by Depuy Mitek, A Johnson & Johnson Company 2 variants

510(k) K060271

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

16 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 NumberK060271 Date4 May 2006ClearedStatusActive

Recalls

16 recalls · FDA

  • 16 recalls, same reason

    • Terminated Z-0146-2013 FDA Class II initiated 6 Sep 2012
    • Terminated Z-0153-2013 FDA Class II initiated 6 Sep 2012
    • Terminated Z-0144-2013 FDA Class II initiated 6 Sep 2012
    • Terminated Z-0147-2013 FDA Class II initiated 6 Sep 2012
    • Terminated Z-0140-2013 FDA Class II initiated 6 Sep 2012
    • Terminated Z-0143-2013 FDA Class II initiated 6 Sep 2012
    • Terminated Z-0141-2013 FDA Class II initiated 6 Sep 2012
    • Terminated Z-0145-2013 FDA Class II initiated 6 Sep 2012
    • Terminated Z-0154-2013 FDA Class II initiated 6 Sep 2012
    • Terminated Z-0148-2013 FDA Class II initiated 6 Sep 2012
    • Terminated Z-0142-2013 FDA Class II initiated 6 Sep 2012
    • Terminated Z-0155-2013 FDA Class II initiated 6 Sep 2012
    • Terminated Z-0150-2013 FDA Class II initiated 6 Sep 2012
    • Terminated Z-0151-2013 FDA Class II initiated 6 Sep 2012
    • Terminated Z-0149-2013 FDA Class II initiated 6 Sep 2012
    • Terminated Z-0152-2013 FDA Class II initiated 6 Sep 2012

    Fracture of SPIRALOK Anchors post op, requiring patient revision

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  • Withdrawn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

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