Incompass Spinal Fixation System

• • Terminated Z-1592-2008 FDA Unclassified (pre-2012) ·initiated 24 Mar 2008 ·on shared 510(k) K021564

  Reports received regarding disassembly of T-Handle Driver components during surgery dropping the closure top into the surgical site.

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

510(k) Number

K021564 ↗

FDA Product Code

KWQ

Device Class

Class II

Regulation

21 CFR Part 888.3060

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Spinal Concepts, Inc. Insight Pedicle Screw System

  Class II

  FDA 510(k) K031855 Active Cleared 17 Sep 2003

• Universal Bone Plate III System (Ubp III)

  Class II

  FDA 510(k) K020611 Active Cleared 27 Mar 2002

• Modification to Incompass Spinal Fixation System

  Class II

  FDA 510(k) K023644 Active Cleared 25 Nov 2002

• Spinal Concepts, Inc., Universal Bone Plate System II

  Class II

  FDA 510(k) K973586 Active Cleared 7 Nov 1997

• Spinal Concepts Cadence and Traxis

  Class II

  FDA 510(k) K033517 Active Cleared 18 Feb 2004

• Harmony Port System, Model 1907 Series

  Class II

  FDA 510(k) K050706 Active Cleared 15 Apr 2005

See all devices from Spinal Concepts, Inc. →