FDA 510(k)

VERTICALE® Triangular Fixation System

Número K: K223806 · 2023-07-06

Data da decisão2023-07-06

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

VERTICALE® Triangular Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Silony Medical GmbH. It received FDA 510(k) clearance on 2023-07-06 under 510(k) number K223806. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the VERTICALE® Triangular Fixation System?

VERTICALE® Triangular Fixation System is a medical device that received FDA 510(k) clearance on 2023-07-06. The listed applicant is Silony Medical GmbH. The 510(k) number is K223806.

When did VERTICALE® Triangular Fixation System receive FDA 510(k) clearance?

VERTICALE® Triangular Fixation System received FDA 510(k) clearance on 2023-07-06, under 510(k) number K223806.

Who is the listed applicant for VERTICALE® Triangular Fixation System?

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

What is the FDA product code for VERTICALE® Triangular Fixation System?

The FDA product code for VERTICALE® Triangular Fixation System is NKB.

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Fonte oficial

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