FDA 510(k)

Sistema de Navegação Cirúrgica ARVIS

Número K: K243980 · 2025-03-21

RequerenteKico Knee Innovation Company Pty Limited

Data da decisão2025-03-21

Código do produtoSBF

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

ARVIS Surgical Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Kico Knee Innovation Company Pty Limited. It received FDA 510(k) clearance on 2025-03-21 under 510(k) number K243980. The device is classified under product code SBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ARVIS Surgical Navigation System?

ARVIS Surgical Navigation System is a medical device that received FDA 510(k) clearance on 2025-03-21. The listed applicant is Kico Knee Innovation Company Pty Limited. The 510(k) number is K243980.

When did ARVIS Surgical Navigation System receive FDA 510(k) clearance?

ARVIS Surgical Navigation System received FDA 510(k) clearance on 2025-03-21, under 510(k) number K243980.

Who is the listed applicant for ARVIS Surgical Navigation System?

The FDA 510(k) record lists Kico Knee Innovation Company Pty Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARVIS Surgical Navigation System?

The FDA product code for ARVIS Surgical Navigation System is SBF.

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Outros registros que listam Kico Knee Innovation Company Pty Limited como candidato(a)

K223927360CAS K213380360CAS K163405Sistema de Posicionamento de Implantes 360KS

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Fonte oficial

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