T2 STRATOSPHERE Expandable Corpectomy System

Spinal Vertebral Body Replacement Device

Medtronic Sofamor Danek, USA Inc.

The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Usa Inc. with the FDA for T2 Stratosphere Expandable Corpectomy System.

Pre-market Notification Details

Device IDK183510
510k NumberK183510
Device Name:T2 STRATOSPHERE Expandable Corpectomy System
ClassificationSpinal Vertebral Body Replacement Device
Applicant Medtronic Sofamor Danek, USA Inc. 1800 Pyramid Place Memphis,  TN  38132
ContactElizabeth Hamilton
CorrespondentElizabeth Hamilton
Medtronic Sofamor Danek, USA Inc. 1800 Pyramid Place Memphis,  TN  38132
Product CodeMQP  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-18
Decision Date2019-01-16
Summary:summary

NIH GUDID Devices

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