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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K100599
Device Name CAS FIXATION PIN 3.2 DIA X 180 MM STR, CAS FIXATON PIN 3.2 DIA X 80 MM STR, CAS FIXATON PIN 3.2 DIA X 150 MM
Applicant
Orthosoft, Inc.
75 Queen St., Suite 3300
Montreal,  CA H3C 2N6
Applicant Contact CHRISTOPHER MCLEAN
Correspondent
Orthosoft, Inc.
75 Queen St., Suite 3300
Montreal,  CA H3C 2N6
Correspondent Contact CHRISTOPHER MCLEAN
Regulation Number882.4560
Classification Product Code
OLO  
Date Received03/03/2010
Decision Date 04/05/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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