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FDA 510(k)

T2 STRATOSPHERE™ Expandable Corpectomy System

K-Number: K173125 · 2017-12-20

ApplicantMedtronic Sofamor Danek
Decision Date2017-12-20
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

T2 STRATOSPHERE™ Expandable Corpectomy System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek. It received FDA 510(k) clearance on 2017-12-20 under 510(k) number K173125. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T2 STRATOSPHERE™ Expandable Corpectomy System?

T2 STRATOSPHERE™ Expandable Corpectomy System is a medical device that received FDA 510(k) clearance on 2017-12-20. The listed applicant is Medtronic Sofamor Danek. The 510(k) number is K173125.

When did T2 STRATOSPHERE™ Expandable Corpectomy System receive FDA 510(k) clearance?

T2 STRATOSPHERE™ Expandable Corpectomy System received FDA 510(k) clearance on 2017-12-20, under 510(k) number K173125.

Who is the listed applicant for T2 STRATOSPHERE™ Expandable Corpectomy System?

The FDA 510(k) record lists Medtronic Sofamor Danek as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for T2 STRATOSPHERE™ Expandable Corpectomy System?

The FDA product code for T2 STRATOSPHERE™ Expandable Corpectomy System is MQP.

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Related Devices (Code: MQP)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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