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Sbi Radio-Capitellar Implant

by Small Bone Innovations, Inc.

510(k) K060038

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

11 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 NumberK060038 Date30 Mar 2006ClearedStatusActive

Recalls

11 recalls · FDA

  • 11 recalls, same reason

    • Terminated Z-2694-2018 FDA Class II initiated 24 Oct 2017
    • Terminated Z-2695-2018 FDA Class II initiated 24 Oct 2017
    • Terminated Z-2710-2018 FDA Class II initiated 24 Oct 2017
    • Terminated Z-2699-2018 FDA Class II initiated 24 Oct 2017
    • Terminated Z-2698-2018 FDA Class II initiated 24 Oct 2017
    • Terminated Z-2696-2018 FDA Class II initiated 24 Oct 2017
    • Terminated Z-2702-2018 FDA Class II initiated 24 Oct 2017
    • Terminated Z-2701-2018 FDA Class II initiated 24 Oct 2017
    • Terminated Z-2693-2018 FDA Class II initiated 24 Oct 2017
    • Terminated Z-2697-2018 FDA Class II initiated 24 Oct 2017
    • Terminated Z-2700-2018 FDA Class II initiated 24 Oct 2017

    Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.

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  • Withdrawn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
JDB
Device Class
Class II
Regulation
21 CFR Part 888.3160
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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