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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, facet screw spinal device
510(k) Number K021705
Device Name MODIFICATION TO TOWNLEY TRANSFACEPEDICULAR SCREW FIXATION SYSTEM
Original Applicant
MEDTRONIC SOFAMOR DANEK, INC.
1800 pyramid place
memphis,  TN  38132
Original Contact richard treharne
Classification Product Code
MRW  
Date Received05/23/2002
Decision Date 07/24/2002
Decision substantially equivalent (SESE)
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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