Modification to Synthes Matrix System

• • Terminated Z-0226-2015 FDA Class I ·initiated 23 Oct 2014

  Two nonconforming parts of the Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws may have been inadvertently packaged and shipped. It is believed that the inner diameter of the Reduction Head may not have been machined to the correct specification.

• • Terminated Z-3207-2011 FDA Unclassified (pre-2012) ·initiated 11 Mar 2011

  Labeling Correction -- The locking cap was not able to be loosened, resulting in the breakage of the screwdriver or the rod to be cut and the assembly to be removed (screw, cap, and rod). This poses a potential risk of significant prolongation of OR time.

510(k) Number

K100952 ↗

FDA Product Code

NKB

Device Class

Class II

Regulation

21 CFR Part 888.3070

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Uss Iliosacral, Uss Polyaxial

  Class II

  FDA 510(k) K082572 Active Cleared 24 Nov 2008

• Oracle Spacer, Opal Spacer

  Class II

  FDA 510(k) K072791 Active Cleared 26 Dec 2007

• Synthes Mirs

  Class II

  FDA 510(k) K113044 Active Cleared 21 Dec 2011

• Synthes Spine Posterior Universal System

  Class II

  FDA 510(k) K984612 Active Cleared 19 Jan 1999

• Synthes Cervifix System

  Class II

  FDA 510(k) K001864 Active Cleared 20 Jul 2000

• Synthes Spine Universal Spinal Hook, Rod, Pedicle/Sacral Screw Fixation System

  Class II

  FDA 510(k) K980928 Active Cleared 11 May 1998

See all devices from Synthes Spine →