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FDA 510(k)

ARIX Cannulated Screw System

K-Number: K233912 · 2024-03-11

ApplicantJeil Medical Corporation
Decision Date2024-03-11
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARIX Cannulated Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Jeil Medical Corporation. It received FDA 510(k) clearance on 2024-03-11 under 510(k) number K233912. 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 2024-03-11. The listed applicant is Jeil Medical Corporation. The 510(k) number is K233912.

When did ARIX Cannulated Screw System receive FDA 510(k) clearance?

ARIX Cannulated Screw System received FDA 510(k) clearance on 2024-03-11, under 510(k) number K233912.

Who is the listed applicant for ARIX Cannulated Screw System?

The FDA 510(k) record lists Jeil Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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