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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 K090224
FOIA Releasable 510(k) K090224
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 Received01/30/2009
Decision Date 07/30/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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