ARIX Cannulated Screw System
K-Number: K192417 · 2019-11-26
ApplicantJeil Medical Corporation
Decision Date2019-11-26
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
ARIX Cannulated Screw System is a medical device manufactured by Jeil Medical Corporation. It received FDA 510(k) clearance on 2019-11-26 under approval number K192417. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ARIX Cannulated Screw System?
ARIX Cannulated Screw System is a medical device that received FDA 510(k) clearance on 2019-11-26. It is manufactured by Jeil Medical Corporation. The 510(k) number is K192417.
When was ARIX Cannulated Screw System approved by the FDA?
ARIX Cannulated Screw System received FDA 510(k) clearance on 2019-11-26, under approval number K192417.
What company makes ARIX Cannulated Screw System?
ARIX Cannulated Screw System is manufactured by Jeil Medical Corporation.
What is the FDA product code for ARIX Cannulated Screw System?
The FDA product code for ARIX Cannulated Screw System is HWC. This falls under the Cardiovascular category.
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Official Source
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