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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 K122326
Model PRO-09001
Device Name SMARTTOOLS KNEE SYSTEM
Original Applicant
ZIMMER
75, queen street
suite 3300
montreal,  CA h3c 2n6
Original Contact christopher mclean
Regulation Number882.4560
Classification Product Code
OLO  
Date Received08/01/2012
Decision Date 11/30/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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