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Synthes (USA) Rapid Resorbable Fixation System

by Synthes (Usa)

510(k) K062789

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK062789 Date27 Feb 2007ClearedStatusActive

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-1919-2016 FDA Class II initiated 2 May 2016
    • Terminated Z-1920-2016 FDA Class II initiated 2 May 2016
    • Terminated Z-1918-2016 FDA Class II initiated 2 May 2016

    Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.

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  • Withdrawn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
JEY
Device Class
Class II
Regulation
21 CFR Part 872.4760
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

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