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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 K120540
Models AR-5100C-07, AR-5100C-08, AR-5100C-09, AR-5100C-10
Device Name BIOBOLT
Original Applicant
1370 creekside blvd.
naples,  FL  34108 1945
Original Contact courtney smith
Regulation Number888.3030
Classification Product Code
Subsequent Product Code
Date Received02/23/2012
Decision Date 03/20/2012
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