FDA 510(k)

PROstep(TM) MIS 5mm Chamfer Screw System

Número K: K221645 · 2023-02-17

Data da decisão2023-02-17

Código do produtoHWC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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