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Synthes (USA) (Synthes) Single Vector Distractor with Detachable Feet

by Synthes (Usa)

510(k) K981075

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

6 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 9 Oct 2026. What this means

Regulatory status

as of registry sync 9 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK981075 Date22 Jun 1998ClearedStatusActive

Recalls

6 recalls · FDA

  • 6 recalls, same reason

    • Terminated Z-2585-2016 FDA Class II initiated 23 May 2016
    • Terminated Z-2583-2016 FDA Class II initiated 23 May 2016
    • Terminated Z-2586-2016 FDA Class II initiated 23 May 2016
    • Terminated Z-2582-2016 FDA Class II initiated 23 May 2016
    • Terminated Z-2581-2016 FDA Class II initiated 23 May 2016
    • Terminated Z-2584-2016 FDA Class II initiated 23 May 2016

    DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely separated from the Proximal Foot Plate.

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  • Withdrawn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

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