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FDA 510(k)

ARIX Wrist System

K-Number: K191972 · 2019-11-12

ApplicantJeil Medical Corporation
Decision Date2019-11-12
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARIX Wrist System is a medical device manufactured by Jeil Medical Corporation. It received FDA 510(k) clearance on 2019-11-12 under approval number K191972. 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 Wrist System?

ARIX Wrist System is a medical device that received FDA 510(k) clearance on 2019-11-12. It is manufactured by Jeil Medical Corporation. The 510(k) number is K191972.

When was ARIX Wrist System approved by the FDA?

ARIX Wrist System received FDA 510(k) clearance on 2019-11-12, under approval number K191972.

What company makes ARIX Wrist System?

ARIX Wrist System is manufactured by Jeil Medical Corporation.

What is the FDA product code for ARIX Wrist System?

The FDA product code for ARIX Wrist 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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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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