FDA 510(k)

CATALYSTEM Femoral Stems

Número K: K250571 · 2025-03-28

Data da decisão2025-03-28

Código do produtoLZO

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

CATALYSTEM Femoral Stems 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 2025-03-28 under 510(k) number K250571. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CATALYSTEM Femoral Stems?

CATALYSTEM Femoral Stems is a medical device that received FDA 510(k) clearance on 2025-03-28. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K250571.

When did CATALYSTEM Femoral Stems receive FDA 510(k) clearance?

CATALYSTEM Femoral Stems received FDA 510(k) clearance on 2025-03-28, under 510(k) number K250571.

Who is the listed applicant for CATALYSTEM Femoral Stems?

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 CATALYSTEM Femoral Stems?

The FDA product code for CATALYSTEM Femoral Stems is LZO.

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Fonte oficial

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