Stryker Spine Trio Spinal Fixation System

• • Terminated Z-1886-2009 FDA Unclassified (pre-2012) ·initiated 1 Jul 2009 ·on shared 510(k) K052971

  The Trio 3.5MM Hex socket has been reported to break under high stresses.

• • Terminated Z-0986-2009 FDA Unclassified (pre-2012) ·initiated 5 Sep 2006

  Reports were received of the ball ring ejecting from the connector's body when other connectors have already been locked down.

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

510(k) Number

K052971 ↗

FDA Product Code

MNI

Device Class

Class II

Regulation

21 CFR Part 888.3070

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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