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FDA 510(k)

Geminus Volar Distal Radius Plate System

K-Number: K182492 · 2018-10-10

ApplicantSkeletal Dynamics, LLC
Decision Date2018-10-10
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Geminus Volar Distal Radius Plate System is a medical device manufactured by Skeletal Dynamics, LLC. It received FDA 510(k) clearance on 2018-10-10 under approval number K182492. 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 Geminus Volar Distal Radius Plate System?

Geminus Volar Distal Radius Plate System is a medical device that received FDA 510(k) clearance on 2018-10-10. It is manufactured by Skeletal Dynamics, LLC. The 510(k) number is K182492.

When was Geminus Volar Distal Radius Plate System approved by the FDA?

Geminus Volar Distal Radius Plate System received FDA 510(k) clearance on 2018-10-10, under approval number K182492.

What company makes Geminus Volar Distal Radius Plate System?

Geminus Volar Distal Radius Plate System is manufactured by Skeletal Dynamics, LLC.

What is the FDA product code for Geminus Volar Distal Radius Plate System?

The FDA product code for Geminus Volar Distal Radius 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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