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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 K100138
Device Name ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
Original Applicant
ALPHATEC SPINE, INC.
5818 el camino real
carlsbad,  CA  92008
Original Contact cheryl allen
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   MNH  
Date Received01/19/2010
Decision Date 02/17/2010
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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