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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name appliance, fixation, spinal interlaminal
510(k) Number K121115
Device Name M.U.S.T PEDICLE SCREW SYSTEM
Original Applicant
MEDACTA INTERNATIONAL
4725 calle quetzal, unit b
camarillo,  CA  93012
Original Contact adam gross
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Codes
KWQ   MNH   MNI   NKB  
Date Received04/12/2012
Decision Date 07/18/2012
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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