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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
Applicant
X-SPINE SYSTEMS, INC
452 Alexandersville Rd
Miamisburg,  OH  45342
Applicant Contact DAVID KIRSCHMAN
Correspondent
X-SPINE SYSTEMS, INC
452 Alexandersville Rd
Miamisburg,  OH  45342
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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