Modification to Endius Atavi System

• • Terminated Z-1045-2013 FDA Class II ·initiated 8 Feb 2013

  Possibility that the inner pouch may be compromised. The product is packaged in two pouches - a sterile inner pouch within an external pouch. NexPosure Retractors contained in a breached inner pouch have an increased risk of contamination (i.e.; loss of product sterility) if proper aseptic technique is not followed when transferring the inner package into the sterile field. Patient infection may o

510(k) Number

K061345 ↗

FDA Product Code

HRX

Device Class

Class II

Regulation

21 CFR Part 888.1100

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. →