FDA 510(k)

Sistema de Placagem Charcot REDEMPTION

Número K: K233816 · 2024-08-28

Data da decisão2024-08-28

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

REDEMPTION Charcot Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Vilex, LLC. It received FDA 510(k) clearance on 2024-08-28 under 510(k) number K233816. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the REDEMPTION Charcot Plating System?

REDEMPTION Charcot Plating System is a medical device that received FDA 510(k) clearance on 2024-08-28. The listed applicant is Vilex, LLC. The 510(k) number is K233816.

When did REDEMPTION Charcot Plating System receive FDA 510(k) clearance?

REDEMPTION Charcot Plating System received FDA 510(k) clearance on 2024-08-28, under 510(k) number K233816.

Who is the listed applicant for REDEMPTION Charcot Plating System?

The FDA 510(k) record lists Vilex, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REDEMPTION Charcot Plating System?

The FDA product code for REDEMPTION Charcot Plating System is HRS.

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Fonte oficial

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