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FDA 510(k)

Lever Action Plate System

K-Number: K200834 · 2020-06-25

ApplicantMcginley Orthpaedic Innovations, LLC
Decision Date2020-06-25
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Lever Action Plate System is a medical device manufactured by Mcginley Orthpaedic Innovations, LLC. It received FDA 510(k) clearance on 2020-06-25 under approval number K200834. 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 Lever Action Plate System?

Lever Action Plate System is a medical device that received FDA 510(k) clearance on 2020-06-25. It is manufactured by Mcginley Orthpaedic Innovations, LLC. The 510(k) number is K200834.

When was Lever Action Plate System approved by the FDA?

Lever Action Plate System received FDA 510(k) clearance on 2020-06-25, under approval number K200834.

What company makes Lever Action Plate System?

Lever Action Plate System is manufactured by Mcginley Orthpaedic Innovations, LLC.

What is the FDA product code for Lever Action Plate System?

The FDA product code for Lever Action Plate 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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