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Anchorlok and Anchorlok Rl Soft Tissue Anchor System

by Wrightmedicaltechnologyinc

510(k) K971282

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 NumberK971282 Date27 Jun 1997ClearedStatusActive

Recalls

10 recalls · FDA

  • 10 recalls, same reason

    • Terminated Z-0059-2012 FDA Unclassified (pre-2012) initiated 20 Sep 2011
    • Terminated Z-0062-2012 FDA Unclassified (pre-2012) initiated 20 Sep 2011
    • Terminated Z-0064-2012 FDA Unclassified (pre-2012) initiated 20 Sep 2011
    • Terminated Z-0066-2012 FDA Unclassified (pre-2012) initiated 20 Sep 2011
    • Terminated Z-0067-2012 FDA Unclassified (pre-2012) initiated 20 Sep 2011
    • Terminated Z-0060-2012 FDA Unclassified (pre-2012) initiated 20 Sep 2011
    • Terminated Z-0063-2012 FDA Unclassified (pre-2012) initiated 20 Sep 2011
    • Terminated Z-0065-2012 FDA Unclassified (pre-2012) initiated 20 Sep 2011
    • Terminated Z-0061-2012 FDA Unclassified (pre-2012) initiated 20 Sep 2011
    • Terminated Z-0058-2012 FDA Unclassified (pre-2012) initiated 20 Sep 2011

    The product is labeled with an expiration date without adequate justification.

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  • Withdrawn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

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