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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 K120832
Device Name FORTEX PEDICLE SCREW SYSTEM
Original Applicant
X-SPINE SYSTEMS, INC
452 alexandersville rd
miamisburg,  OH  45342
Original Contact david kirschman
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received03/19/2012
Decision Date 10/23/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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