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FDA 510(k)

StealthStation Cranial Software v1.3.2

K-Number: K203639 · 2021-01-13

ApplicantMedtronic Navigation, Inc.
Decision Date2021-01-13
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

StealthStation Cranial Software v1.3.2 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 2021-01-13 under 510(k) number K203639. 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 Cranial Software v1.3.2?

StealthStation Cranial Software v1.3.2 is a medical device that received FDA 510(k) clearance on 2021-01-13. The listed applicant is Medtronic Navigation, Inc.. The 510(k) number is K203639.

When did StealthStation Cranial Software v1.3.2 receive FDA 510(k) clearance?

StealthStation Cranial Software v1.3.2 received FDA 510(k) clearance on 2021-01-13, under 510(k) number K203639.

Who is the listed applicant for StealthStation Cranial Software v1.3.2?

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 Cranial Software v1.3.2?

The FDA product code for StealthStation Cranial Software v1.3.2 is HAW.

Other records listing Medtronic Navigation, Inc. as applicant

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.

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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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