Navigus II Trajectory Guide

• • Terminated Z-0849-2008 FDA Unclassified (pre-2012) ·initiated 4 Oct 2007

  Sterilty (package integrity) Compromised: Some failures were for damage to the outer pouch, while another set of failures were for the seals on this pouch. The seal between the inner tray and lid has not been compromised and the contents remain sterile, however, the sterility of the outer surfaces of the inner tray and lid cannot be assured.

510(k) Number

K012366 ↗

FDA Product Code

HAW

Device Class

Class II

Regulation

21 CFR Part 882.4560

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Trajectory Guide, Model # Tgx-Xxx

  Class II

  FDA 510(k) K983539 Active Cleared 12 Feb 1999

• Navigus Reusable Passive Probe, Model Sp-2000

  Class II

  FDA 510(k) K050772 Active Cleared 21 Apr 2005

• Navigus Fiducial Marker System, Models Fm-1000, Fm-2000

  Class II

  FDA 510(k) K024201 Active Cleared 12 Mar 2003

• Remote Introducer, Model Pi-1000

  Class II

  FDA 510(k) K990907 Active Cleared 12 Aug 1999

• Navigus Unibody Fiducial Marker System, Model Fm-4000

  Class II

  FDA 510(k) K033619 Active Cleared 2 Mar 2004

• Burr Hole Cover, Model Xx Open recall

  Class II

  FDA 510(k) K001096 Active Cleared 25 Oct 2000

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