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 the device name listed in this FDA 510(k) record. The listed applicant is Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2016-11-03 under 510(k) 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. The listed applicant is Synthes (USA) Products, LLC. The 510(k) number is K161590.

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

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

Who is the listed applicant for MatrixRIB Fixation System?

The FDA 510(k) record lists Synthes (USA) Products, LLC as the applicant. This does not by itself establish the device manufacturer.

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.