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FDA 510(k)

Geminus Volar Distal Radius Plating System

K-Number: K252949 · 2025-11-13

ApplicantSkeletal Dynamics, Inc.
Decision Date2025-11-13
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Geminus Volar Distal Radius Plating System is a medical device manufactured by Skeletal Dynamics, Inc.. It received FDA 510(k) clearance on 2025-11-13 under approval number K252949. 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 Plating System?

Geminus Volar Distal Radius Plating System is a medical device that received FDA 510(k) clearance on 2025-11-13. It is manufactured by Skeletal Dynamics, Inc.. The 510(k) number is K252949.

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

Geminus Volar Distal Radius Plating System received FDA 510(k) clearance on 2025-11-13, under approval number K252949.

What company makes Geminus Volar Distal Radius Plating System?

Geminus Volar Distal Radius Plating System is manufactured by Skeletal Dynamics, Inc..

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

The FDA product code for Geminus Volar Distal Radius Plating System is HRS.

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Other Devices by Skeletal Dynamics, Inc.

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Related Devices (Code: 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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