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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 K113755
Device Name SAVANNAH TECHNOLOGIES SPINAL SYSTEM
Original Applicant
SAVANNAH TECHNOLOGIES LLC
1001 oakwood blvd.
round rock,  TX  78681
Original Contact j.d. webb
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received12/21/2011
Decision Date 02/01/2012
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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