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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 K010249
Device Name CD HORIZON SPINAL SYSTEM
Applicant
MEDTRONIC SOFAMOR DANEK, INC.
1800 PYRAMID PLACE
MEMPHIS,  TN  38132
Applicant Contact RICHARD W TREHARNE
Correspondent
MEDTRONIC SOFAMOR DANEK, INC.
1800 PYRAMID PLACE
MEMPHIS,  TN  38132
Correspondent Contact RICHARD W TREHARNE
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   KWQ   MNI  
Date Received01/26/2001
Decision Date 02/23/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
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