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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name plate, fixation, bone
510(k) Number K122334
Device Name CHECKMATE SMALL BONE FUSION SYSTEM
Original Applicant
ARTHROSURFACE, INC.
28 forge parkway
franklin,  MA  02038
Original Contact dawn j wilson
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received08/06/2012
Decision Date 11/28/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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