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FDA 510(k)

Facet Screw Fixation System

K-Number: K173198 · 2018-01-03

Decision Date2018-01-03
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

Facet Screw Fixation System is a medical device manufactured by U&I Corporation. It received FDA 510(k) clearance on 2018-01-03 under approval 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. It is manufactured by U&I Corporation. The 510(k) number is K173198.

When was Facet Screw Fixation System approved by the FDA?

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

What company makes Facet Screw Fixation System?

Facet Screw Fixation System is manufactured by U&I Corporation.

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

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

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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.