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FDA 510(k)

Fortis and Hana Anterior Cervical Plate System

K-Number: K173099 · 2017-11-30

Decision Date2017-11-30
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Fortis and Hana Anterior Cervical Plate System is a medical device manufactured by Huvexel Co. , Ltd.. It received FDA 510(k) clearance on 2017-11-30 under approval number K173099. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fortis and Hana Anterior Cervical Plate System?

Fortis and Hana Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2017-11-30. It is manufactured by Huvexel Co. , Ltd.. The 510(k) number is K173099.

When was Fortis and Hana Anterior Cervical Plate System approved by the FDA?

Fortis and Hana Anterior Cervical Plate System received FDA 510(k) clearance on 2017-11-30, under approval number K173099.

What company makes Fortis and Hana Anterior Cervical Plate System?

Fortis and Hana Anterior Cervical Plate System is manufactured by Huvexel Co. , Ltd..

What is the FDA product code for Fortis and Hana Anterior Cervical Plate System?

The FDA product code for Fortis and Hana Anterior Cervical Plate System is KWQ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.