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FDA 510(k)

ARIX Foot System (2.3/2.8)

K-Number: K170780 · 2017-08-14

ApplicantJeil Medical Corporation
Decision Date2017-08-14
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARIX Foot System (2.3/2.8) 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 2017-08-14 under 510(k) number K170780. 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 Foot System (2.3/2.8)?

ARIX Foot System (2.3/2.8) is a medical device that received FDA 510(k) clearance on 2017-08-14. The listed applicant is Jeil Medical Corporation. The 510(k) number is K170780.

When did ARIX Foot System (2.3/2.8) receive FDA 510(k) clearance?

ARIX Foot System (2.3/2.8) received FDA 510(k) clearance on 2017-08-14, under 510(k) number K170780.

Who is the listed applicant for ARIX Foot System (2.3/2.8)?

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 Foot System (2.3/2.8)?

The FDA product code for ARIX Foot System (2.3/2.8) 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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