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FDA 510(k)

ARIX Ankle Distal Tibia System

K-Number: K202912 · 2020-10-29

ApplicantJeil Medical Corporation
Decision Date2020-10-29
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARIX Ankle Distal Tibia 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 2020-10-29 under 510(k) number K202912. 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 Ankle Distal Tibia System?

ARIX Ankle Distal Tibia System is a medical device that received FDA 510(k) clearance on 2020-10-29. The listed applicant is Jeil Medical Corporation. The 510(k) number is K202912.

When did ARIX Ankle Distal Tibia System receive FDA 510(k) clearance?

ARIX Ankle Distal Tibia System received FDA 510(k) clearance on 2020-10-29, under 510(k) number K202912.

Who is the listed applicant for ARIX Ankle Distal Tibia 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 Ankle Distal Tibia System?

The FDA product code for ARIX Ankle Distal Tibia System is HRS.

Related Clinical Trials

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.

NCT05662449A Cohort Study of Bioabsorbable Screws for Syndesmosis Fixation Fixation in Ankle FractureCOMPLETED

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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.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

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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