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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, for degenerative disc disease
510(k) Number K122433
Device Name CD HORIZON SPINAL SYSTEM
Original Applicant
MEDTRONIC SOFAMOR DANEK, INC.
1800 pyramid place
memphis,  TN  38132
Original Contact chris mckee
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI   OSH  
Date Received08/10/2012
Decision Date 09/28/2012
Decision substantially equivalent - with limitations (SU)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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