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FDA 510(k)

Avanti Distal Radius and Forearm System

K-Number: K191118 · 2019-12-13

ApplicantAvanti Orthopaedics, Inc.
Decision Date2019-12-13
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Avanti Distal Radius and Forearm System is a medical device manufactured by Avanti Orthopaedics, Inc.. It received FDA 510(k) clearance on 2019-12-13 under approval number K191118. 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 Avanti Distal Radius and Forearm System?

Avanti Distal Radius and Forearm System is a medical device that received FDA 510(k) clearance on 2019-12-13. It is manufactured by Avanti Orthopaedics, Inc.. The 510(k) number is K191118.

When was Avanti Distal Radius and Forearm System approved by the FDA?

Avanti Distal Radius and Forearm System received FDA 510(k) clearance on 2019-12-13, under approval number K191118.

What company makes Avanti Distal Radius and Forearm System?

Avanti Distal Radius and Forearm System is manufactured by Avanti Orthopaedics, Inc..

What is the FDA product code for Avanti Distal Radius and Forearm System?

The FDA product code for Avanti Distal Radius and Forearm System is 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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