TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES


Device Classification Name

neurological stereotaxic instrument

510(k) Number K081232
Device Name TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES
Applicant
PRAXIM
le grand sablon
4 avenue de l’obiou
la tronche, 

FR

38700

Applicant Contact annie pollier
Correspondent
PRAXIM
le grand sablon
4 avenue de l’obiou
la tronche, 

FR

38700

Correspodent Contact annie pollier
Regulation Number 882.4560
Classification Product Code
HAW  
Date Received 05/01/2008
Decision Date 08/06/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No