ARIX Ankle Distal Tibia System
K-Number: K202912 · 2020-10-29
ApplicantJeil Medical Corporation
Decision Date2020-10-29
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
ARIX Ankle Distal Tibia System is a medical device manufactured by Jeil Medical Corporation. It received FDA 510(k) clearance on 2020-10-29 under approval number K202912. 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 Ankle Distal Tibia System?
ARIX Ankle Distal Tibia System is a medical device that received FDA 510(k) clearance on 2020-10-29. It is manufactured by Jeil Medical Corporation. The 510(k) number is K202912.
When was ARIX Ankle Distal Tibia System approved by the FDA?
ARIX Ankle Distal Tibia System received FDA 510(k) clearance on 2020-10-29, under approval number K202912.
What company makes ARIX Ankle Distal Tibia System?
ARIX Ankle Distal Tibia System is manufactured by Jeil Medical Corporation.
What is the FDA product code for ARIX Ankle Distal Tibia System?
The FDA product code for ARIX Ankle Distal Tibia 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.