FDA 510(k)

JOURNEY II Unicompartmental Knee System (JOURNEY II UK)

Número K: K242711 · 2024-10-30

Data da decisão2024-10-30

Código do produtoHSX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

JOURNEY II Unicompartmental Knee System (JOURNEY II UK) is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2024-10-30 under 510(k) number K242711. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the JOURNEY II Unicompartmental Knee System (JOURNEY II UK)?

JOURNEY II Unicompartmental Knee System (JOURNEY II UK) is a medical device that received FDA 510(k) clearance on 2024-10-30. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K242711.

When did JOURNEY II Unicompartmental Knee System (JOURNEY II UK) receive FDA 510(k) clearance?

JOURNEY II Unicompartmental Knee System (JOURNEY II UK) received FDA 510(k) clearance on 2024-10-30, under 510(k) number K242711.

Who is the listed applicant for JOURNEY II Unicompartmental Knee System (JOURNEY II UK)?

The FDA 510(k) record lists Smith & Nephew, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JOURNEY II Unicompartmental Knee System (JOURNEY II UK)?

The FDA product code for JOURNEY II Unicompartmental Knee System (JOURNEY II UK) is HSX.

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Outros registros que listam Smith & Nephew, Inc. como candidato(a)

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Fonte oficial

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