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FDA 510(k)

FaSet Fixation System

K-Number: K180729 · 2018-06-28

ApplicantHuvexel Co. , Ltd.
Decision Date2018-06-28
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

FaSet Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Huvexel Co. , Ltd.. It received FDA 510(k) clearance on 2018-06-28 under 510(k) number K180729. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FaSet Fixation System?

FaSet Fixation System is a medical device that received FDA 510(k) clearance on 2018-06-28. The listed applicant is Huvexel Co. , Ltd.. The 510(k) number is K180729.

When did FaSet Fixation System receive FDA 510(k) clearance?

FaSet Fixation System received FDA 510(k) clearance on 2018-06-28, under 510(k) number K180729.

Who is the listed applicant for FaSet Fixation System?

The FDA 510(k) record lists Huvexel Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FaSet Fixation System?

The FDA product code for FaSet Fixation System is MRW.

Other records listing Huvexel Co. , Ltd. as applicant

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Related Devices (Code: MRW)

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.

K261209Ion-LSurGenTec, LLCK253676CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)Providence Medical Technology, Inc.K253432DiversiVy™ Facet Screw SystemVy Spine, LLCK251714Ion-CSurGenTec, LLCK250679FFX Facet Fixation SystemSc MedicaK253190CORUS-LX ImplantProvidence Medical Technology, 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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