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FDA 510(k)

MatrixRIB Fixation System

K-Number: K161590 · 2016-11-03

Decision Date2016-11-03
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MatrixRIB Fixation System is a medical device manufactured by Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2016-11-03 under approval number K161590. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MatrixRIB Fixation System?

MatrixRIB Fixation System is a medical device that received FDA 510(k) clearance on 2016-11-03. It is manufactured by Synthes (USA) Products, LLC. The 510(k) number is K161590.

When was MatrixRIB Fixation System approved by the FDA?

MatrixRIB Fixation System received FDA 510(k) clearance on 2016-11-03, under approval number K161590.

What company makes MatrixRIB Fixation System?

MatrixRIB Fixation System is manufactured by Synthes (USA) Products, LLC.

What is the FDA product code for MatrixRIB Fixation System?

The FDA product code for MatrixRIB Fixation System is HRS.

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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.