NAVITRACK SYSTEM TOTAL HIP REPLACEMENT,MODEL 900.200


Device Classification Name

neurological stereotaxic instrument

510(k) Number K022364
Device Name NAVITRACK SYSTEM TOTAL HIP REPLACEMENT,MODEL 900.200
Original Applicant
ORTHOSOFT, INC.
75 queen st., suite 3300
montreal, quebec, 

CA

h3c 2n6

Original Contact christopher mclean
Regulation Number 882.4560
Classification Product Code
HAW  
Date Received 07/22/2002
Decision Date 02/04/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No