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FDA 510(k)

Navigated T2 STRATOSPHERE Inserters and Navigated Templates

K-Number: K191039 · 2019-08-26

ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2019-08-26
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Navigated T2 STRATOSPHERE Inserters and Navigated Templates is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2019-08-26 under 510(k) number K191039. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Navigated T2 STRATOSPHERE Inserters and Navigated Templates?

Navigated T2 STRATOSPHERE Inserters and Navigated Templates is a medical device that received FDA 510(k) clearance on 2019-08-26. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K191039.

When did Navigated T2 STRATOSPHERE Inserters and Navigated Templates receive FDA 510(k) clearance?

Navigated T2 STRATOSPHERE Inserters and Navigated Templates received FDA 510(k) clearance on 2019-08-26, under 510(k) number K191039.

Who is the listed applicant for Navigated T2 STRATOSPHERE Inserters and Navigated Templates?

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

What is the FDA product code for Navigated T2 STRATOSPHERE Inserters and Navigated Templates?

The FDA product code for Navigated T2 STRATOSPHERE Inserters and Navigated Templates is OLO.

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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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