Medtronic Snt Stealthstation Axiem Imageless Knee Module

• • Terminated Z-0718-06 FDA Unclassified (pre-2012) ·initiated 1 Feb 2006

  Knee Navigation Disposable Kits were programmed with an incorrect identification number on the tracker ROM chip which would not permit navigation during surgery.

510(k) Number

K043088 ↗

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

• 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

• Stealthstation System Advanced Contour Registration Software Module

  Class II

  FDA 510(k) K030106 Active Cleared 12 Feb 2003

See all devices from Medtronic Surgical Navigation Technologies →