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FDA 510(k)

Treace Medical Concepts (TMC) Hammertoe Fixation System

K-Number: K222564 · 2022-11-15

ApplicantTreace Medical Concepts, Inc.
Decision Date2022-11-15
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Treace Medical Concepts (TMC) Hammertoe 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 2022-11-15 under 510(k) number K222564. 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) Hammertoe Fixation System?

Treace Medical Concepts (TMC) Hammertoe Fixation System is a medical device that received FDA 510(k) clearance on 2022-11-15. The listed applicant is Treace Medical Concepts, Inc.. The 510(k) number is K222564.

When did Treace Medical Concepts (TMC) Hammertoe Fixation System receive FDA 510(k) clearance?

Treace Medical Concepts (TMC) Hammertoe Fixation System received FDA 510(k) clearance on 2022-11-15, under 510(k) number K222564.

Who is the listed applicant for Treace Medical Concepts (TMC) Hammertoe 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 Treace Medical Concepts (TMC) Hammertoe Fixation System?

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

Other records listing Treace Medical Concepts, Inc. as applicant

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Related Devices (Code: HWC)

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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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