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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name orthosis, spondylolisthesis spinal fixation
510(K) Number K122814
Device Name GALLEON PEDICLE SCREW SYSTEM
Applicant
EVEREST SPINE, LLC
33650 reserve way
avon,  OH  44011
Contact christina vacca
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received09/13/2012
Decision Date 12/03/2012
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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