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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 K173125
Device Name T2 STRATOSPHERE™ Expandable Corpectomy System
Applicant
Medtronic Sofamor Danek
1800 Pyramid Place
Memphis,  TX  38132
Applicant Contact Kanesha Hines
Correspondent
Medtronic Sofamor Danek
1800 Pyramid Place
Memphis,  TN  38132
Correspondent Contact Kanesha Hines
Regulation Number888.3060
Classification Product Code
MQP  
Date Received09/29/2017
Decision Date 12/20/2017
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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