510(k) Premarket Notification

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New Search Back To Search Results Device Classification Name orthosis, spinal pedicle fixation 510(k) Number K062934 Device Name SIERRA Applicant SEASPINE, INC. 2302 la mirada dr. vista,  CA  92081 786 Contact diana smith Regulation Number 888.3070 Classification Product Code MNI   Subsequent Product Code KWP   Date Received 09/28/2006 Decision Date 11/16/2006 Decision substantially equivalent (SE) Classification Advisory Committee Orthopedic Review Advisory Committee Orthopedic Statement/Summary/Purged Status Summary only summary summary Type Traditional Reviewed by Third Party No Expedited Review No