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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spinal Pedicle Fixation
510(k) Number K031655
Device Name CD HORIZON SPINAL SYSTEM
Applicant
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Pl.
Memphis,  TN  38132
Applicant Contact RICHARD W TREHARNE, PHD
Correspondent
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Pl.
Memphis,  TN  38132
Correspondent Contact RICHARD W TREHARNE, PHD
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   KWQ   MNH  
Date Received05/28/2003
Decision Date 06/27/2003
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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