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FDA 510(k)

Treace Medical Concepts (TMC) Screw Fixation System

K-Number: K213036 · 2021-10-21

ApplicantTreace Medical Concepts, Inc.
Decision Date2021-10-21
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Treace Medical Concepts (TMC) Screw Fixation System is a medical device manufactured by Treace Medical Concepts, Inc.. It received FDA 510(k) clearance on 2021-10-21 under approval number K213036. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Treace Medical Concepts (TMC) Screw Fixation System?

Treace Medical Concepts (TMC) Screw Fixation System is a medical device that received FDA 510(k) clearance on 2021-10-21. It is manufactured by Treace Medical Concepts, Inc.. The 510(k) number is K213036.

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

Treace Medical Concepts (TMC) Screw Fixation System received FDA 510(k) clearance on 2021-10-21, under approval number K213036.

What company makes Treace Medical Concepts (TMC) Screw Fixation System?

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

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

The FDA product code for Treace Medical Concepts (TMC) Screw Fixation System is HWC. This falls under the Cardiovascular category.

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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.

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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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