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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 K030827
Device Name NAVITRACK SYSTEM: TOTAL HIP REPLACEMENT CT-FREE CUP, MODEL 900.204
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 Received03/14/2003
Decision Date 05/23/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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