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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 Pkwy.
Franklin,  MA  02038
Applicant Contact DAWN J WILSON
Correspondent
Arthrosurface, Inc.
28 Forge Pkwy.
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
Predetermined Change
Control Plan Authorized		 No
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