Endius Title 2 Polyaxial Spinal System

• • Terminated Z-0574-2015 FDA Class II ·initiated 26 Aug 2013

  Possibility of the weld to the quick-connect breaking when force is applied to the handle for pedicle screw removal. A broken weld could lead to the use of an alternate method of screw removal, which could delay surgery up to 30 minutes.

510(k) Number

K041808 ↗

FDA Product Code

KWP

Device Class

Class II

Regulation

21 CFR Part 888.3050

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Endius Flextip Blade

  Class II

  FDA 510(k) K022578 Active Cleared 23 Aug 2002

• Endius Minit Posterior Cervical and Upper Thoracic Fixation System

  Class II

  FDA 510(k) K060683 Active Cleared 18 Apr 2006

• Endius Spinal Fixation System

  Class II

  FDA 510(k) K014090 Active Cleared 11 Mar 2002

• Endius Title 2 Polyaxial Spinal System

  Class II

  FDA 510(k) K070367 Active Cleared 12 Apr 2007

• Endius Endoscopic Access System

  Class II

  FDA 510(k) K002437 Active Cleared 2 Oct 2000

• Endius Spine Endoscope

  Class II

  FDA 510(k) K982819 Active Cleared 27 Jan 1999

See all devices from Endius, Inc. →