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FDA 510(k)

Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4

K-Number: K221087 · 2022-06-10

ApplicantMedtronic Navigation, Inc.
Decision Date2022-06-10
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 is a medical device manufactured by Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2022-06-10 under approval number K221087. 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 Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4?

Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 is a medical device that received FDA 510(k) clearance on 2022-06-10. It is manufactured by Medtronic Navigation, Inc.. The 510(k) number is K221087.

When was Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 approved by the FDA?

Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 received FDA 510(k) clearance on 2022-06-10, under approval number K221087.

What company makes Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4?

Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 is manufactured by Medtronic Navigation, Inc..

What is the FDA product code for Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4?

The FDA product code for Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 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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