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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K021760
Device Name NAVITRACK SYSTEM-OPTICAL TKR CT-LESS, MODEL 900.120
Applicant
ORTHOSOFT, INC.
75 QUEEN ST., SUITE 3300
MONTREAL, QUEBEC,  CA H3C 2N6
Applicant Contact CHRISTOPHER MCLEAN
Correspondent
ORTHOSOFT, INC.
75 QUEEN ST., SUITE 3300
MONTREAL, QUEBEC,  CA H3C 2N6
Correspondent Contact CHRISTOPHER MCLEAN
Regulation Number882.4560
Classification Product Code
HAW  
Date Received05/29/2002
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
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