FDA 510(k)

Treace Medical Concepts (TMC) Snap-Off Screw System

Número K: K183363 · 2019-06-13

Data da decisão2019-06-13

Código do produtoHWC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Treace Medical Concepts (TMC) Snap-Off Screw 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 2019-06-13 under 510(k) number K183363. 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) Snap-Off Screw System?

Treace Medical Concepts (TMC) Snap-Off Screw System is a medical device that received FDA 510(k) clearance on 2019-06-13. The listed applicant is Treace Medical Concepts, Inc.. The 510(k) number is K183363.

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

Treace Medical Concepts (TMC) Snap-Off Screw System received FDA 510(k) clearance on 2019-06-13, under 510(k) number K183363.

Who is the listed applicant for Treace Medical Concepts (TMC) Snap-Off Screw 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) Snap-Off Screw System?

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

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Outros registros que listam Treace Medical Concepts, Inc. como candidato(a)

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Fonte oficial

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