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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
Applicant
ARTHROSURFACE, INC.
28 FORGE PARKWAY
FRANKLIN,  MA  02038
Applicant Contact DAWN J WILSON
Correspondent
ARTHROSURFACE, INC.
28 FORGE PARKWAY
FRANKLIN,  MA  02038
Correspondent Contact DAWN J WILSON
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received08/02/2012
Decision Date 11/28/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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