FDA 510(k)

Treace Medical Concepts (TMC) Plating System

K-Number: K221181 · 2023-01-05

Decision Date2023-01-05

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Treace Medical Concepts (TMC) Plating System is a medical device manufactured by Treace Medical Concepts, Inc.. It received FDA 510(k) clearance on 2023-01-05 under approval number K221181. 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 Concepts (TMC) Plating System?

Treace Medical Concepts (TMC) Plating System is a medical device that received FDA 510(k) clearance on 2023-01-05. It is manufactured by Treace Medical Concepts, Inc.. The 510(k) number is K221181.

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

Treace Medical Concepts (TMC) Plating System received FDA 510(k) clearance on 2023-01-05, under approval number K221181.

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

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

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

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

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Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

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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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.