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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name posterior metal/polymer spinal system, fusion
510(k) Number K072321
Device Name BIOFLEX
Original Applicant
BIOSPINE CO., LTD.
1331 h street nw, 12th floor
washington,  DC  20005
Original Contact justin eggleton
Regulation Number888.3070
Classification Product Code
NQP  
Date Received08/20/2007
Decision Date 03/25/2008
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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