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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 the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2019-07-31 under 510(k) 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. The listed applicant is Medtronic Navigation, Inc.. The 510(k) number is K190672.

When did StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 receive FDA 510(k) clearance?

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 510(k) number K190672.

Who is the listed applicant for StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1?

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

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 records listing Medtronic Navigation, Inc. as applicant

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Related Devices (Code: HAW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261932Leksell® Vantage Stereotactic SystemElekta Solutions ABK253663Zeta Navigation SystemZeta Surgical, Inc.K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical PartnersK250893Ball Joint Guide Array (66295)Bayer Medical Care, Inc.

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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