FDA 510(k)

SternalPlate Expansion

Número K: K243491 · 2024-12-11

RequerenteStryker Leibinger GmbH & Co KG

Data da decisão2024-12-11

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

SternalPlate Expansion 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 2024-12-11 under 510(k) number K243491. 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 SternalPlate Expansion?

SternalPlate Expansion is a medical device that received FDA 510(k) clearance on 2024-12-11. The listed applicant is Stryker Leibinger GmbH & Co KG. The 510(k) number is K243491.

When did SternalPlate Expansion receive FDA 510(k) clearance?

SternalPlate Expansion received FDA 510(k) clearance on 2024-12-11, under 510(k) number K243491.

Who is the listed applicant for SternalPlate Expansion?

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 SternalPlate Expansion?

The FDA product code for SternalPlate Expansion is HRS.

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Fonte oficial

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