510(k) Premarket Notification

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New Search Back To Search Results Device Classification Name rod, fixation, intramedullary and accessories 510(k) Number K060921 Device Name S2 RECON NAIL SYSTEM Applicant HOWMEDICA OSTEONICS CORP. 325 corporate drive mahwah,  NJ  07430 Contact francisco haro Regulation Number 888.3020 Classification Product Code HSB   Date Received 04/04/2006 Decision Date 04/13/2006 Decision substantially equivalent (SE) Classification Advisory Committee Orthopedic Review Advisory Committee Orthopedic Statement/Summary/Purged Status Summary only summary summary Type Special Reviewed by Third Party No Expedited Review No