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FDA 510(k)

Freefix Forearm Plating System

K-Number: K242055 · 2024-08-01

ApplicantSkeletal Dynamics, Inc.
Decision Date2024-08-01
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Freefix Forearm Plating System is a medical device manufactured by Skeletal Dynamics, Inc.. It received FDA 510(k) clearance on 2024-08-01 under approval number K242055. 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 Freefix Forearm Plating System?

Freefix Forearm Plating System is a medical device that received FDA 510(k) clearance on 2024-08-01. It is manufactured by Skeletal Dynamics, Inc.. The 510(k) number is K242055.

When was Freefix Forearm Plating System approved by the FDA?

Freefix Forearm Plating System received FDA 510(k) clearance on 2024-08-01, under approval number K242055.

What company makes Freefix Forearm Plating System?

Freefix Forearm Plating System is manufactured by Skeletal Dynamics, Inc..

What is the FDA product code for Freefix Forearm Plating System?

The FDA product code for Freefix Forearm Plating System is HRS.

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Other Devices by Skeletal Dynamics, Inc.

K201962Skeletal Dynamics Ulnar Shortening Plating System K201662REDUCT® Headless Compression Screw System K200538Skeletal Dynamics Forearm Plating System K200701Skeletal Dynamics Midshaft Humerus Plating System K200367Distal Humerus Plating System K211439Small Bone Nailing System

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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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