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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 K042402
Device Name MODIFICATION TO VERTEX RECONSTRUCTION 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 Received09/03/2004
Decision Date 10/01/2004
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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