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Variax 2 Compression Plating System

by Stryker Trauma AG 2 variants

510(k) K130009

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 NumberK130009 Date22 Mar 2013ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1507-2016 FDA Class II initiated 10 Oct 2013 on shared 510(k) K130009

    Stryker received two reports indicating that during screw insertion under a high lateral angle a bone screw went through a oblong hole.

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  • Withdrawn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
HRS
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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