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FDA 510(k)

ARIX Sternal System

K-Number: K181806 · 2018-11-20

ApplicantJeil Medical Corporation
Decision Date2018-11-20
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARIX Sternal System is the device name listed in this FDA 510(k) record. The listed applicant is Jeil Medical Corporation. It received FDA 510(k) clearance on 2018-11-20 under 510(k) number K181806. 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 ARIX Sternal System?

ARIX Sternal System is a medical device that received FDA 510(k) clearance on 2018-11-20. The listed applicant is Jeil Medical Corporation. The 510(k) number is K181806.

When did ARIX Sternal System receive FDA 510(k) clearance?

ARIX Sternal System received FDA 510(k) clearance on 2018-11-20, under 510(k) number K181806.

Who is the listed applicant for ARIX Sternal System?

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

What is the FDA product code for ARIX Sternal System?

The FDA product code for ARIX Sternal System is HRS.

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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.

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