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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 K001066
Device Name CD HORIZON ECLIPSE
Applicant
MEDTRONIC SOFAMOR DANEK, INC.
1800 PYRAMID PLACE
MEMPHIS,  TN  38132
Applicant Contact RICHARD TREHARNE
Correspondent
MEDTRONIC SOFAMOR DANEK, INC.
1800 PYRAMID PLACE
MEMPHIS,  TN  38132
Correspondent Contact RICHARD TREHARNE
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   KWQ   MNI  
Date Received04/03/2000
Decision Date 06/22/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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