FDA 510(k)

Stryker Resorbable Fixation System

N.º K: K230733 · 2023-08-05

SolicitanteStryker Leibinger GmbH & Co KG

Fecha de decisión2023-08-05

Código de productoJEY

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Stryker Resorbable Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Leibinger GmbH & Co KG. It received FDA 510(k) clearance on 2023-08-05 under 510(k) number K230733. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Stryker Resorbable Fixation System?

Stryker Resorbable Fixation System is a medical device that received FDA 510(k) clearance on 2023-08-05. The listed applicant is Stryker Leibinger GmbH & Co KG. The 510(k) number is K230733.

When did Stryker Resorbable Fixation System receive FDA 510(k) clearance?

Stryker Resorbable Fixation System received FDA 510(k) clearance on 2023-08-05, under 510(k) number K230733.

Who is the listed applicant for Stryker Resorbable Fixation System?

The FDA 510(k) record lists Stryker Leibinger GmbH & Co KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stryker Resorbable Fixation System?

The FDA product code for Stryker Resorbable Fixation System is JEY.

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Fuente oficial

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