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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
Device Name SMARTTOOLS KNEE SYSTEM
Applicant
ZIMMER
75, QUEEN STREET
SUITE 3300
MONTREAL,  CA H3C 2N6
Applicant Contact CHRISTOPHER MCLEAN
Correspondent
ZIMMER
75, QUEEN STREET
SUITE 3300
MONTREAL,  CA H3C 2N6
Correspondent Contact CHRISTOPHER MCLEAN
Regulation Number882.4560
Classification Product Code
OLO  
Date Received08/01/2012
Decision Date 11/30/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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