ARIX Foot System (2.3/2.8)
K-Number: K170780 · 2017-08-14
ApplicantJeil Medical Corporation
Decision Date2017-08-14
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
ARIX Foot System (2.3/2.8) is a medical device manufactured by Jeil Medical Corporation. It received FDA 510(k) clearance on 2017-08-14 under approval number K170780. 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 Foot System (2.3/2.8)?
ARIX Foot System (2.3/2.8) is a medical device that received FDA 510(k) clearance on 2017-08-14. It is manufactured by Jeil Medical Corporation. The 510(k) number is K170780.
When was ARIX Foot System (2.3/2.8) approved by the FDA?
ARIX Foot System (2.3/2.8) received FDA 510(k) clearance on 2017-08-14, under approval number K170780.
What company makes ARIX Foot System (2.3/2.8)?
ARIX Foot System (2.3/2.8) is manufactured by Jeil Medical Corporation.
What is the FDA product code for ARIX Foot System (2.3/2.8)?
The FDA product code for ARIX Foot System (2.3/2.8) 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.