ARIX Humerus System
K-Number: K172008 · 2017-12-01
ApplicantJeil Medical Corporation
Decision Date2017-12-01
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
ARIX Humerus System is a medical device manufactured by Jeil Medical Corporation. It received FDA 510(k) clearance on 2017-12-01 under approval number K172008. 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 Humerus System?
ARIX Humerus System is a medical device that received FDA 510(k) clearance on 2017-12-01. It is manufactured by Jeil Medical Corporation. The 510(k) number is K172008.
When was ARIX Humerus System approved by the FDA?
ARIX Humerus System received FDA 510(k) clearance on 2017-12-01, under approval number K172008.
What company makes ARIX Humerus System?
ARIX Humerus System is manufactured by Jeil Medical Corporation.
What is the FDA product code for ARIX Humerus System?
The FDA product code for ARIX Humerus 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.