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FDA 510(k)

TMC Implant Fixation System

K-Number: K262963 · 2026-09-15

Decision Date2026-09-15
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TMC Implant Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Treace Medical Concepts, Inc.. It received FDA 510(k) clearance on 2026-09-15 under 510(k) number K262963. 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 TMC Implant Fixation System?

TMC Implant Fixation System is a medical device that received FDA 510(k) clearance on 2026-09-15. The listed applicant is Treace Medical Concepts, Inc.. The 510(k) number is K262963.

When did TMC Implant Fixation System receive FDA 510(k) clearance?

TMC Implant Fixation System received FDA 510(k) clearance on 2026-09-15, under 510(k) number K262963.

Who is the listed applicant for TMC Implant Fixation System?

The FDA 510(k) record lists Treace Medical Concepts, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TMC Implant Fixation System?

The FDA product code for TMC Implant Fixation System is HRS.

Other records listing Treace Medical Concepts, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: HRS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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