NAVITRACK SYSTEM-OPTICAL TKR CT-LESS, MODEL 900.120


Device Classification Name

neurological stereotaxic instrument

510(k) Number K021760
Device Name NAVITRACK SYSTEM-OPTICAL TKR CT-LESS, MODEL 900.120
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 05/29/2002
Decision Date 08/27/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No