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FDA 510(k)

ARIX Ankle System

K-Number: K231441 · 2023-07-17

ApplicantJeil Medical Corporation
Decision Date2023-07-17
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARIX Ankle System is a medical device manufactured by Jeil Medical Corporation. It received FDA 510(k) clearance on 2023-07-17 under approval number K231441. 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 System?

ARIX Ankle System is a medical device that received FDA 510(k) clearance on 2023-07-17. It is manufactured by Jeil Medical Corporation. The 510(k) number is K231441.

When was ARIX Ankle System approved by the FDA?

ARIX Ankle System received FDA 510(k) clearance on 2023-07-17, under approval number K231441.

What company makes ARIX Ankle System?

ARIX Ankle System is manufactured by Jeil Medical Corporation.

What is the FDA product code for ARIX Ankle System?

The FDA product code for ARIX Ankle System is HRS.

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Other Devices by Jeil Medical Corporation

K163308SMARTO K161746ARIX Hand System K161864ARIX Foot System K151468ARIX Wrist System K172008ARIX Humerus System K170705ARIX Wrist System

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Related Devices (Code: HRS)

K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc. K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5Aap Implantate AG K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5Aap Implantate AG

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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