FDA 510(k)

Treace Medical Systems (TMC) Plating System

K-Number: K240173 · 2024-02-22

Decision Date2024-02-22

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Treace Medical Systems (TMC) Plating System is a medical device manufactured by Treace Medical Concepts, Inc.. It received FDA 510(k) clearance on 2024-02-22 under approval number K240173. 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 Treace Medical Systems (TMC) Plating System?

Treace Medical Systems (TMC) Plating System is a medical device that received FDA 510(k) clearance on 2024-02-22. It is manufactured by Treace Medical Concepts, Inc.. The 510(k) number is K240173.

When was Treace Medical Systems (TMC) Plating System approved by the FDA?

Treace Medical Systems (TMC) Plating System received FDA 510(k) clearance on 2024-02-22, under approval number K240173.

What company makes Treace Medical Systems (TMC) Plating System?

Treace Medical Systems (TMC) Plating System is manufactured by Treace Medical Concepts, Inc..

What is the FDA product code for Treace Medical Systems (TMC) Plating System?

The FDA product code for Treace Medical Systems (TMC) Plating System is HRS.

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Other Devices by Treace Medical Concepts, Inc.

K153531Treace Medical Concepts (TMC) Plating System K172617Treace Medical Concepts (TMC) Compression Screw System K173930PYTHON Plate Trial Instruments K192504Treace Medical Concepts (TMC) Plating System K183363Treace Medical Concepts (TMC) Snap-Off Screw System K183321Treace Medical Concepts (TMC) Plating System

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Related Devices (Code: HRS)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.