IMAGELESS KNEE MODULE FOR THE STEALTHSTATION SYSTEM


Device Classification Name

neurological stereotaxic instrument

510(k) Number K030552
Device Name IMAGELESS KNEE MODULE FOR THE STEALTHSTATION SYSTEM
Applicant
MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES
826 coal creek circle
louisville, 
CO 
80027

Applicant Contact victoria g rendon
Correspondent
MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES
826 coal creek circle
louisville, 
CO 
80027

Correspodent Contact victoria g rendon
Regulation Number 882.4560
Classification Product Code
HAW  
Date Received 02/21/2003
Decision Date 03/19/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No