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FDA 510(k)

PROstep(TM) MIS 5mm Chamfer Screw System

N.º K: K221645 · 2023-02-17

SolicitanteWright Medical Technology
Fecha de decisión2023-02-17
Código de productoHWC
Comité asesorOR
DecisiónSubstantially Equivalent

Resumen del dispositivo

PROstep(TM) MIS 5mm Chamfer Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Wright Medical Technology. It received FDA 510(k) clearance on 2023-02-17 under 510(k) number K221645. 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.

Preguntas frecuentes

What is the PROstep(TM) MIS 5mm Chamfer Screw System?

PROstep(TM) MIS 5mm Chamfer Screw System is a medical device that received FDA 510(k) clearance on 2023-02-17. The listed applicant is Wright Medical Technology. The 510(k) number is K221645.

When did PROstep(TM) MIS 5mm Chamfer Screw System receive FDA 510(k) clearance?

PROstep(TM) MIS 5mm Chamfer Screw System received FDA 510(k) clearance on 2023-02-17, under 510(k) number K221645.

Who is the listed applicant for PROstep(TM) MIS 5mm Chamfer Screw System?

The FDA 510(k) record lists Wright Medical Technology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROstep(TM) MIS 5mm Chamfer Screw System?

The FDA product code for PROstep(TM) MIS 5mm Chamfer Screw System is HWC. This falls under the Cardiovascular category.

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Dispositivos relacionados (Código: HWC)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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