FDA 510(k)

RibPlate System

Número K: K261054 · 2026-07-01

RequerenteStryker Leibinger GmbH & Co KG

Data da decisão2026-07-01

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

RibPlate 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 2026-07-01 under 510(k) number K261054. 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 RibPlate System?

RibPlate System is a medical device that received FDA 510(k) clearance on 2026-07-01. The listed applicant is Stryker Leibinger GmbH & Co KG. The 510(k) number is K261054.

When did RibPlate System receive FDA 510(k) clearance?

RibPlate System received FDA 510(k) clearance on 2026-07-01, under 510(k) number K261054.

Who is the listed applicant for RibPlate 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 RibPlate System?

The FDA product code for RibPlate System is HRS.

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Fonte oficial

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