ARIX Small Fragment System
K-Number: K221920 · 2022-08-24
ApplicantJeil Medical Corporation
Decision Date2022-08-24
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
ARIX Small Fragment System is a medical device manufactured by Jeil Medical Corporation. It received FDA 510(k) clearance on 2022-08-24 under approval number K221920. 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 Small Fragment System?
ARIX Small Fragment System is a medical device that received FDA 510(k) clearance on 2022-08-24. It is manufactured by Jeil Medical Corporation. The 510(k) number is K221920.
When was ARIX Small Fragment System approved by the FDA?
ARIX Small Fragment System received FDA 510(k) clearance on 2022-08-24, under approval number K221920.
What company makes ARIX Small Fragment System?
ARIX Small Fragment System is manufactured by Jeil Medical Corporation.
What is the FDA product code for ARIX Small Fragment System?
The FDA product code for ARIX Small Fragment 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.