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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 K050809
Device Name CD HORIZON SPINAL SYSTEM
Original Applicant
MEDTRONIC SOFAMOR DANEK USA, INC.
1800 pyramid place
memphis,  TN  38132
Original Contact richard treharne
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Codes
KWQ   MNH   MNI   NKB  
Date Received03/31/2005
Decision Date 06/14/2005
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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