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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name orthosis, spondylolisthesis spinal fixation
510(k) Number K000641
Device Name CD HORIZON SPINAL SYSTEM
Original Applicant
MEDTRONIC SOFAMOR DANEK, INC.
1800 pyramid place
memphis,  TN  38132
Original Contact richard w treharne
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   KWQ   MNI  
Date Received02/25/2000
Decision Date 12/22/2000
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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