Skip to content

Osteoraptor Suture Anchor

by Smith & Nephew Inc., Endoscopy Division

510(k) K082215

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

9 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 NumberK082215 Date3 Nov 2008ClearedStatusActive

Recalls

9 recalls · FDA

  • 9 recalls, same reason

    • Terminated Z-2223-2013 FDA Class II initiated 6 Aug 2013
    • Terminated Z-2226-2013 FDA Class II initiated 6 Aug 2013
    • Terminated Z-2222-2013 FDA Class II initiated 6 Aug 2013
    • Terminated Z-2220-2013 FDA Class II initiated 6 Aug 2013
    • Terminated Z-2224-2013 FDA Class II initiated 6 Aug 2013
    • Terminated Z-2221-2013 FDA Class II initiated 6 Aug 2013
    • Terminated Z-2228-2013 FDA Class II initiated 6 Aug 2013
    • Terminated Z-2227-2013 FDA Class II initiated 6 Aug 2013
    • Terminated Z-2225-2013 FDA Class II initiated 6 Aug 2013

    Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

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  • Withdrawn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
JDR
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from Smith & Nephew Inc., Endoscopy Division

See all devices from Smith & Nephew Inc., Endoscopy Division →