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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K132111
Device Name CD HORIZON SPINAL SYSTEM
Applicant
Medtronic Sofamor Danek USA
1800 Pyramid Place
Memphis,  TN  38132
Applicant Contact LAUREN KAMER
Correspondent
Medtronic Sofamor Danek USA
1800 Pyramid Place
Memphis,  TN  38132
Correspondent Contact LAUREN KAMER
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI   OSH  
Date Received07/09/2013
Decision Date 08/06/2013
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
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