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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinal Vertebral Body Replacement Device
510(k) Number K023570
Device Name MODIFICATION TO VERTE-STACK SPINAL SYSTEM
Applicant
Medtronic Sofamor Danek
1800 Pyramid Place
Memphis,  TN  38132
Applicant Contact RICHARD W TREHARNE
Correspondent
Medtronic Sofamor Danek
1800 Pyramid Place
Memphis,  TN  38132
Correspondent Contact RICHARD W TREHARNE
Regulation Number888.3060
Classification Product Code
MQP  
Date Received10/24/2002
Decision Date 11/19/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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