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FDA 510(k)

ARIX Rib System

K-Number: K221412 · 2022-11-22

ApplicantJeil Medical Corporation
Decision Date2022-11-22
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARIX Rib 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 2022-11-22 under 510(k) number K221412. 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 Rib System?

ARIX Rib System is a medical device that received FDA 510(k) clearance on 2022-11-22. The listed applicant is Jeil Medical Corporation. The 510(k) number is K221412.

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

ARIX Rib System received FDA 510(k) clearance on 2022-11-22, under 510(k) number K221412.

Who is the listed applicant for ARIX Rib 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 Rib System?

The FDA product code for ARIX Rib System is HRS.

Other records listing Jeil Medical Corporation as applicant

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Related Devices (Code: HRS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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