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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 K060615
Device Name CD HORIZON SPINAL SYSTEM
Applicant
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis,  TN  38132
Contact richard treharne
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI   NQP  
Date Received03/07/2006
Decision Date 10/25/2006
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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