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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name fastener, fixation, biodegradable, soft tissue
510(k) Number K122228
Device Name LIGAFIX INTERFERENCE SCREW
Original Applicant
SBM SCIENCES FOR BIO MATERIALS
zi du monge
lourdes,  FR 65100
Original Contact denis clement
Regulation Number888.3030
Classification Product Code
MAI  
Date Received08/01/2012
Decision Date 10/03/2012
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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