ARIX Diaphysis System
K-Number: K171285 · 2017-07-24
ApplicantJeil Medical Corporation
Decision Date2017-07-24
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
ARIX Diaphysis System is a medical device manufactured by Jeil Medical Corporation. It received FDA 510(k) clearance on 2017-07-24 under approval number K171285. 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 Diaphysis System?
ARIX Diaphysis System is a medical device that received FDA 510(k) clearance on 2017-07-24. It is manufactured by Jeil Medical Corporation. The 510(k) number is K171285.
When was ARIX Diaphysis System approved by the FDA?
ARIX Diaphysis System received FDA 510(k) clearance on 2017-07-24, under approval number K171285.
What company makes ARIX Diaphysis System?
ARIX Diaphysis System is manufactured by Jeil Medical Corporation.
What is the FDA product code for ARIX Diaphysis System?
The FDA product code for ARIX Diaphysis 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.