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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Interlaminal
510(k) Number K020426
Device Name MSD WIRE SYSTEM
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 Number888.3050
Classification Product Code
KWP  
Date Received02/08/2002
Decision Date 02/26/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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