Stealthstation Treatment Guidance Platform

• • Terminated Z-1234-2016 FDA Class II ·initiated 22 Feb 2016

  Medtronic Navigation is recalling the Biotex Adapter Kit because it was commercially distributed by BioTex without a cleared premarket [510(k)] from FDA.

510(k) Number

K003201 ↗

FDA Product Code

HAW

Device Class

Class II

Regulation

21 CFR Part 882.4560

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Hip Module for the Stealthstation System

  Class II

  FDA 510(k) K021980 Active Cleared 19 Nov 2002

• Medtronic Snt Stealthstation Axiem Imageless Knee Module

  Class II

  FDA 510(k) K043088 Active Cleared 5 Jan 2005

• Stealthstation with Fluoromerge Software

  Class II

  FDA 510(k) K020338 Active Cleared 27 Feb 2002

• Imageless Knee Module for the Stealthstation System

  Class II

  FDA 510(k) K030552 Active Cleared 19 Mar 2003

• Stealthstation System Goldeneye Micro-Magnetic Tracking System

  Class II

  FDA 510(k) K001284 Active Cleared 12 Jun 2000

• Stealthstation System Three Dimensional C-Arm Interface

  Class II

  FDA 510(k) K022414 Active Cleared 14 Aug 2002

See all devices from Medtronic Surgical Navigation Technologies →