FDA 510(k)

Treace Medical Concepts (TMC) Screw Fixation System

Número K: K260361 · 2026-03-06

Data da decisão2026-03-06

Código do produtoHWC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Treace Medical Concepts (TMC) Screw 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 2026-03-06 under 510(k) number K260361. 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.

Perguntas frequentes

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 2026-03-06. The listed applicant is Treace Medical Concepts, Inc.. The 510(k) number is K260361.

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

Treace Medical Concepts (TMC) Screw Fixation System received FDA 510(k) clearance on 2026-03-06, under 510(k) number K260361.

Who is the listed applicant for Treace Medical Concepts (TMC) Screw 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) 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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Outros registros que listam Treace Medical Concepts, Inc. como candidato(a)

K262963TMC Implant Fixation System K242671Treace Medical Concepts (TMC) Screw Fixation System K240173Treace Medical Systems (TMC) Plating System K221181Treace Medical Concepts (TMC) Plating System K222564Treace Medical Concepts (TMC) Hammertoe Fixation System K220136Treace Medical Concepts (TMC) Plating System

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Fonte oficial

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