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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 K013962
Device Name EQUATION FIXATION SYSTEM
Original Applicant
MEDTRONIC SOFAMOR DANEK, INC.
1800 pyramid place
memphis,  TN  38132
Original Contact richard treharne
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received12/03/2001
Decision Date 06/20/2002
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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