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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 Interlaminal
510(k) Number K102886
Device Name CD HORIZON SPINAL SYSTEM
Applicant
Medtronic Sofamor Danek, Inc.
1800 Pyramid Pl.
Memphis,  TN  38132
Applicant Contact LEE GRANT
Correspondent
Medtronic Sofamor Danek, Inc.
1800 Pyramid Pl.
Memphis,  TN  38132
Correspondent Contact LEE GRANT
Regulation Number888.3050
Classification Product Code
KWP  
Date Received09/30/2010
Decision Date 01/26/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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