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FDA 510(k)

Arzzt Distal Radius and Ulna System

K-Number: K182650 · 2019-06-10

ApplicantTruemed Group, LLC
Decision Date2019-06-10
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arzzt Distal Radius and Ulna System is a medical device manufactured by Truemed Group, LLC. It received FDA 510(k) clearance on 2019-06-10 under approval number K182650. 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 Arzzt Distal Radius and Ulna System?

Arzzt Distal Radius and Ulna System is a medical device that received FDA 510(k) clearance on 2019-06-10. It is manufactured by Truemed Group, LLC. The 510(k) number is K182650.

When was Arzzt Distal Radius and Ulna System approved by the FDA?

Arzzt Distal Radius and Ulna System received FDA 510(k) clearance on 2019-06-10, under approval number K182650.

What company makes Arzzt Distal Radius and Ulna System?

Arzzt Distal Radius and Ulna System is manufactured by Truemed Group, LLC.

What is the FDA product code for Arzzt Distal Radius and Ulna System?

The FDA product code for Arzzt Distal Radius and Ulna System is HRS.

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Other Devices by Truemed Group, LLC

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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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