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510(k) K173125

T2 STRATOSPHERE™ Expandable Corpectomy System by Medtronic Sofamor Danek — Product Code MQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2017
Date Received
September 29, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spinal Vertebral Body Replacement Device
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

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