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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name pin, fixation, smooth
510(k) Number K112197
Model SMART TO / X-FUSE
Device Name MEMOMETAL INTRA-MEDULLARY BONE FASTENER
Original Applicant
MEMOMETAL TECHNOLOGIES
campus de ker lann
rue blaise pascal
bruz,  FR f35170
Original Contact gilles audic
Regulation Number888.3040
Classification Product Code
HTY  
Date Received08/01/2011
Decision Date 11/17/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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