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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K042025
Device Name MODIFICATION TO CD HORIZON SPINAL SYSTEM
Applicant
Medtronic Sofamor Danek, Inc.
1800 Pyramid Place
Memphis,  TN  38132
Applicant Contact RICHARD TREHARNE
Correspondent
Medtronic Sofamor Danek, Inc.
1800 Pyramid Place
Memphis,  TN  38132
Correspondent Contact RICHARD TREHARNE
Regulation Number888.3060
Classification Product Code
KWQ  
Subsequent Product Codes
KWP   MNH   MNI  
Date Received07/28/2004
Decision Date 08/25/2004
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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