ARIX Ankle Fibula Hook Plate System
K-Number: K170979 · 2017-08-17
ApplicantJeil Medical Corporation
Decision Date2017-08-17
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
ARIX Ankle Fibula Hook Plate System is a medical device manufactured by Jeil Medical Corporation. It received FDA 510(k) clearance on 2017-08-17 under approval number K170979. 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 Fibula Hook Plate System?
ARIX Ankle Fibula Hook Plate System is a medical device that received FDA 510(k) clearance on 2017-08-17. It is manufactured by Jeil Medical Corporation. The 510(k) number is K170979.
When was ARIX Ankle Fibula Hook Plate System approved by the FDA?
ARIX Ankle Fibula Hook Plate System received FDA 510(k) clearance on 2017-08-17, under approval number K170979.
What company makes ARIX Ankle Fibula Hook Plate System?
ARIX Ankle Fibula Hook Plate System is manufactured by Jeil Medical Corporation.
What is the FDA product code for ARIX Ankle Fibula Hook Plate System?
The FDA product code for ARIX Ankle Fibula Hook Plate 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.