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FDA 510(k)

Fiagon Navigation System

K-Number: K163209 · 2017-09-14

ApplicantFiagon GmbH
Decision Date2017-09-14
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Fiagon Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Fiagon GmbH. It received FDA 510(k) clearance on 2017-09-14 under 510(k) number K163209. 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 Fiagon Navigation System?

Fiagon Navigation System is a medical device that received FDA 510(k) clearance on 2017-09-14. The listed applicant is Fiagon GmbH. The 510(k) number is K163209.

When did Fiagon Navigation System receive FDA 510(k) clearance?

Fiagon Navigation System received FDA 510(k) clearance on 2017-09-14, under 510(k) number K163209.

Who is the listed applicant for Fiagon Navigation System?

The FDA 510(k) record lists Fiagon GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fiagon Navigation System?

The FDA product code for Fiagon Navigation System is HAW.

Other records listing Fiagon GmbH 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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