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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 K091883
Device Name T2 SPINAL SYSTEM
Applicant
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis,  TN  38132
Applicant Contact THERESA LEISTER
Correspondent
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis,  TN  38132
Correspondent Contact THERESA LEISTER
Regulation Number888.3060
Classification Product Code
MQP  
Date Received06/24/2009
Decision Date 09/21/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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