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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name orthosis, spinal pedicle fixation
510(K) Number K122332
Device Name TOWERLOX PEDICLE SCREW SYSTEM
Applicant
CAPTIVA SPINE
13540 guild ave
apple vally,  MN  55124
Contact rich jansen
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received08/06/2012
Decision Date 10/16/2012
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
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