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FDA 510(k)

ARIX Pectus Bar System

K-Number: K242751 · 2025-05-30

Decision Date2025-05-30
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARIX Pectus Bar System is a medical device manufactured by Jeil Medical Corporation. It received FDA 510(k) clearance on 2025-05-30 under approval number K242751. 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 Pectus Bar System?

ARIX Pectus Bar System is a medical device that received FDA 510(k) clearance on 2025-05-30. It is manufactured by Jeil Medical Corporation. The 510(k) number is K242751.

When was ARIX Pectus Bar System approved by the FDA?

ARIX Pectus Bar System received FDA 510(k) clearance on 2025-05-30, under approval number K242751.

What company makes ARIX Pectus Bar System?

ARIX Pectus Bar System is manufactured by Jeil Medical Corporation.

What is the FDA product code for ARIX Pectus Bar System?

The FDA product code for ARIX Pectus Bar System is HRS.

Other Devices by Jeil Medical Corporation

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Related Devices (Code: HRS)

Official Source

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