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FDA 510(k)

ARIX Elbow System

K-Number: K201656 · 2020-09-15

ApplicantJeil Medical Corporation
Decision Date2020-09-15
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARIX Elbow System is a medical device manufactured by Jeil Medical Corporation. It received FDA 510(k) clearance on 2020-09-15 under approval number K201656. 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 Elbow System?

ARIX Elbow System is a medical device that received FDA 510(k) clearance on 2020-09-15. It is manufactured by Jeil Medical Corporation. The 510(k) number is K201656.

When was ARIX Elbow System approved by the FDA?

ARIX Elbow System received FDA 510(k) clearance on 2020-09-15, under approval number K201656.

What company makes ARIX Elbow System?

ARIX Elbow System is manufactured by Jeil Medical Corporation.

What is the FDA product code for ARIX Elbow System?

The FDA product code for ARIX Elbow System is HRS.

Related Clinical Trials

NCT03487250 Percutaneous US Guided Elbow Tenotomy With the TenJet HydroSurgery System COMPLETED NCT07520851 Efficacy of the Buzzy System on Pain and Fear Reduction in Elbow Fracture Pin Removal RECRUITING NCT06772142 Early Feasibility of the Nervonik Peripheral Nerve Stimulation Device RECRUITING NCT07495254 Effectiveness of Combined Super Inductive System (SIS) Therapy With Therapeutic Exercise and Health Education in Lateral Elbow Tendinopathy NOT_YET_RECRUITING

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)

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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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