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Reflex Hybrid Anterior Cervical Plate System

by Stryker Spine

510(k) K040261

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 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 NumberK040261 Date16 Apr 2004ClearedStatusActive

Recalls

4 recalls · FDA

    • Terminated Z-0217-2009 FDA Unclassified (pre-2012) initiated 18 Aug 2008

    The Reflex Hybrid 4.0 x 14 mm Variable, Self Tapping Bone Screw, Lot NSZ, was determined to have been anodized with the incorrect color for that screw.

  • 3 recalls, same reason

    • Terminated Z-1960-2009 FDA Unclassified (pre-2012) initiated 14 Jun 2006
    • Terminated Z-1959-2009 FDA Unclassified (pre-2012) initiated 14 Jun 2006
    • Terminated Z-1958-2009 FDA Unclassified (pre-2012) initiated 14 Jun 2006

    Design Flaw: The design did not prevent over angulation of the screws when the recommended instrument, All in One Guide, was not used.

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  • Withdrawn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
KWQ
Device Class
Class II
Regulation
21 CFR Part 888.3060
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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