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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 K060336
Device Name NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002
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 Received02/10/2006
Decision Date 04/28/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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