FDA 510(k)

LANDMARK Total Knee System

Número K: K261462 · 2026-09-08

Data da decisão2026-09-08

Código do produtoMBH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

LANDMARK Total Knee System 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 2026-09-08 under 510(k) number K261462. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the LANDMARK Total Knee System?

LANDMARK Total Knee System is a medical device that received FDA 510(k) clearance on 2026-09-08. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K261462.

When did LANDMARK Total Knee System receive FDA 510(k) clearance?

LANDMARK Total Knee System received FDA 510(k) clearance on 2026-09-08, under 510(k) number K261462.

Who is the listed applicant for LANDMARK Total Knee System?

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 LANDMARK Total Knee System?

The FDA product code for LANDMARK Total Knee System is MBH.

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

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Fonte oficial

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