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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
Applicant Contact richard treharne
Correspondent
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis,  TN  38132
Correspodent 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 (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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