FDA 510(k)

Allure Cadeira de Quadril e Plugs Intramedulares

Número K: K250375 · 2025-11-05

Data da decisão2025-11-05

Código do produtoMEH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Allure Hip Stem and Intramedullary Plugs is the device name listed in this FDA 510(k) record. The listed applicant is Waldemar Link GmbH & Co. KG. It received FDA 510(k) clearance on 2025-11-05 under 510(k) number K250375. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Allure Hip Stem and Intramedullary Plugs?

Allure Hip Stem and Intramedullary Plugs is a medical device that received FDA 510(k) clearance on 2025-11-05. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K250375.

When did Allure Hip Stem and Intramedullary Plugs receive FDA 510(k) clearance?

Allure Hip Stem and Intramedullary Plugs received FDA 510(k) clearance on 2025-11-05, under 510(k) number K250375.

Who is the listed applicant for Allure Hip Stem and Intramedullary Plugs?

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

What is the FDA product code for Allure Hip Stem and Intramedullary Plugs?

The FDA product code for Allure Hip Stem and Intramedullary Plugs is MEH.

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Fonte oficial

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