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FDA 510(k)

StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1

K-Number: K190672 · 2019-07-31

ApplicantMedtronic Navigation, Inc.
Decision Date2019-07-31
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 is a medical device manufactured by Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2019-07-31 under approval number K190672. 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 StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1?

StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 is a medical device that received FDA 510(k) clearance on 2019-07-31. It is manufactured by Medtronic Navigation, Inc.. The 510(k) number is K190672.

When was StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 approved by the FDA?

StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 received FDA 510(k) clearance on 2019-07-31, under approval number K190672.

What company makes StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1?

StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 is manufactured by Medtronic Navigation, Inc..

What is the FDA product code for StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1?

The FDA product code for StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 is HAW.

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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