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FDA 510(k)

Facet Screw Fixation System

K-Number: K173198 · 2018-01-03

ApplicantU&I Corporation
Decision Date2018-01-03
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

Facet Screw Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is U&I Corporation. It received FDA 510(k) clearance on 2018-01-03 under 510(k) number K173198. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Facet Screw Fixation System?

Facet Screw Fixation System is a medical device that received FDA 510(k) clearance on 2018-01-03. The listed applicant is U&I Corporation. The 510(k) number is K173198.

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

Facet Screw Fixation System received FDA 510(k) clearance on 2018-01-03, under 510(k) number K173198.

Who is the listed applicant for Facet Screw Fixation System?

The FDA 510(k) record lists U&I Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Facet Screw Fixation System?

The FDA product code for Facet Screw Fixation System is MRW.

Related Clinical Trials

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NCT07222787Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion OutcomesRECRUITING

Other records listing U&I Corporation as applicant

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K220147Aspiron S ACP SystemK210573Velofix SA Cervical CageK183243Velofix TLIF CageK190067Velofix Interbody Fusion SystemK190053SECULOK™ ACP SystemK181824CBT Screw Fixation System

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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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