Skip to content

Tag Rod Bioraptor Suture Anchor 7209317, 7209318

by Smith & Nephew, Inc.

510(k) K031685

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 · Special NumberK031685 Date1 Jul 2003ClearedStatusActive

Recalls

5 recalls · FDA

  • 5 recalls, same reason

    • Terminated Z-2216-2013 FDA Class II initiated 6 Aug 2013
    • Terminated Z-2219-2013 FDA Class II initiated 6 Aug 2013
    • Terminated Z-2217-2013 FDA Class II initiated 6 Aug 2013
    • Terminated Z-2215-2013 FDA Class II initiated 6 Aug 2013
    • Terminated Z-2218-2013 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  • Withdrawn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
HWC
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →