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Sbi Ulnar Head Implant

by Small Bone Innovations, Inc.

510(k) K061146

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 NumberK061146 Date19 Jul 2006ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2427-2015 FDA Class II initiated 24 Jun 2015
    • Terminated Z-2430-2015 FDA Class II initiated 24 Jun 2015

    Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromised by transportation.

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  • Withdrawn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
KXE
Device Class
Class II
Regulation
21 CFR Part 888.3810
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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