Hip Module for the Stealthstation System

• • Terminated Z-0923-2010 FDA Unclassified (pre-2012) ·initiated 3 Nov 2009

  Orthopedic clamp may slip if used with non-indicated system, resulting in possible inaccurate navigation information being displayed.

• • Terminated Z-0231-04 FDA Unclassified (pre-2012) ·initiated 31 Oct 2003

  Surgical devices intended for single use were not labeled for single use.

510(k) Number

K021980 ↗

FDA Product Code

HAW

Device Class

Class II

Regulation

21 CFR Part 882.4560

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• 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

• 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 →