Skip to content

Sbi Lateral Radio Capitellum

by Small Bone Innovations, Inc.

510(k) K070236

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 NumberK070236 Date21 Feb 2007ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-2428-2015 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.

    • Terminated Z-0098-2014 FDA Class II initiated 6 Sep 2013 on shared 510(k) K070236

    The recall was initiated due to an increased risk of implants breaching the sterile pouches inside the shrink-wrapped box.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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

Other devices from Small Bone Innovations, Inc.

See all devices from Small Bone Innovations, Inc. →