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FDA 510(k)

Stealth Autoguide System, Midas Rex Legend Depth Stop System

K-Number: K191597 · 2019-11-01

ApplicantMedtronic Navigation, Inc.
Decision Date2019-11-01
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Stealth Autoguide System, Midas Rex Legend Depth Stop System is a medical device manufactured by Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2019-11-01 under approval number K191597. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stealth Autoguide System, Midas Rex Legend Depth Stop System?

Stealth Autoguide System, Midas Rex Legend Depth Stop System is a medical device that received FDA 510(k) clearance on 2019-11-01. It is manufactured by Medtronic Navigation, Inc.. The 510(k) number is K191597.

When was Stealth Autoguide System, Midas Rex Legend Depth Stop System approved by the FDA?

Stealth Autoguide System, Midas Rex Legend Depth Stop System received FDA 510(k) clearance on 2019-11-01, under approval number K191597.

What company makes Stealth Autoguide System, Midas Rex Legend Depth Stop System?

Stealth Autoguide System, Midas Rex Legend Depth Stop System is manufactured by Medtronic Navigation, Inc..

What is the FDA product code for Stealth Autoguide System, Midas Rex Legend Depth Stop System?

The FDA product code for Stealth Autoguide System, Midas Rex Legend Depth Stop System is HAW.

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Other Devices by Medtronic Navigation, Inc.

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Related Devices (Code: HAW)

K162604Cranial Reducing TubesMedtronic Navigation, Inc. K160811CRW STEREOTACTIC SYSTEMIntegra LifeSciences Corporation K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. K152764EXACTECH GPSBlue Ortho K160523BrightMatter Guide with BrightMatter PointerSynaptive Medical, Inc. K151156Fiagon Navigation SystemFiagon GmbH

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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