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 a medical device manufactured by Jeil Medical Corporation. It received FDA 510(k) clearance on 2018-11-20 under approval 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. It is manufactured by Jeil Medical Corporation. The 510(k) number is K181806.
When was ARIX Sternal System approved by the FDA?
ARIX Sternal System received FDA 510(k) clearance on 2018-11-20, under approval number K181806.
What company makes ARIX Sternal System?
ARIX Sternal System is manufactured by Jeil Medical Corporation.
What is the FDA product code for ARIX Sternal System?
The FDA product code for ARIX Sternal System is HRS.
Related Clinical Trials
Other Devices by Jeil Medical Corporation
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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.