Cadence Spinal Fixation System

• • Terminated Z-0190-2007 FDA Unclassified (pre-2012) ·initiated 5 Oct 2006

  Zimmer Spine, Inc. is conducting a RECALL of all manufacturing lots of ST360 Distal Thread Reduction Guide Pins due to an issue with the thread timing.

510(k) Number

K022374 ↗

FDA Product Code

KWP

Device Class

Class II

Regulation

21 CFR Part 888.3050

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Silhouette Spinal Fixation System Modification

  Class II

  FDA 510(k) K992276 Active Cleared 1 Oct 1999

• Silhouette Spinal Fixation System

  Class II

  FDA 510(k) K993067 Active Cleared 16 Nov 1999

• Modification to Silhouette Spinal Fixation System

  Class II

  FDA 510(k) K020196 Active Cleared 15 Feb 2002

• Modification to: Trinica Anterior Cervical Plate System

  Class II

  FDA 510(k) K012305 Active Cleared 22 Aug 2001

• Device Modification of Silhouette Spindal Fixation System

  Class II

  FDA 510(k) K012173 Active Cleared 28 Sep 2001

• Rpx Titanium Cemnt Restrictor

  Class II

  FDA 510(k) K020344 Active Cleared 2 May 2002

See all devices from Sulzer Spine-Tech →