T2 STRATOSPHERE™ Expandable Corpectomy System

Spinal Vertebral Body Replacement Device

Medtronic Sofamor Danek

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

Pre-market Notification Details

Device IDK173125
510k NumberK173125
Device Name:T2 STRATOSPHERE™ Expandable Corpectomy System
ClassificationSpinal Vertebral Body Replacement Device
Applicant Medtronic Sofamor Danek 1800 Pyramid Place Memphis,  TX  38132
ContactKanesha Hines
CorrespondentKanesha Hines
Medtronic Sofamor Danek 1800 Pyramid Place Memphis,  TN  38132
Product CodeMQP  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-29
Decision Date2017-12-20
Summary:summary

NIH GUDID Devices

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Trademark Results [T2 STRATOSPHERE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
T2 STRATOSPHERE
T2 STRATOSPHERE
86817545 5546279 Live/Registered
Warsaw Orthopedic, Inc.
2015-11-12

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