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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name thoracolumbosacral pedicle screw system
510(k) Number K091974
Device Name MODIFICATION TO CD HORIZON SPINAL SYSTEM
Applicant
MEDTRONIC SOFAMOR DANEK USA, INC.
1800 PYRAMID PLACE
MEMPHIS,  TN  38132
Applicant Contact CHRIS MCKEE
Correspondent
MEDTRONIC SOFAMOR DANEK USA, INC.
1800 PYRAMID PLACE
MEMPHIS,  TN  38132
Correspondent Contact CHRIS MCKEE
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI   NQP  
Date Received07/01/2009
Decision Date 09/02/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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