FDA 510(k)

Sistema de Quadril Ativo-V; World Total Knee System

Número K: K253239 · 2025-12-23

RequerenteSignature Orthopaedics Pty, Ltd.

Data da decisão2025-12-23

Código do produtoMBH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Active-V Total Knee System; World Total Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2025-12-23 under 510(k) number K253239. 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 Active-V Total Knee System; World Total Knee System?

Active-V Total Knee System; World Total Knee System is a medical device that received FDA 510(k) clearance on 2025-12-23. The listed applicant is Signature Orthopaedics Pty, Ltd.. The 510(k) number is K253239.

When did Active-V Total Knee System; World Total Knee System receive FDA 510(k) clearance?

Active-V Total Knee System; World Total Knee System received FDA 510(k) clearance on 2025-12-23, under 510(k) number K253239.

Who is the listed applicant for Active-V Total Knee System; World Total Knee System?

The FDA 510(k) record lists Signature Orthopaedics Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Active-V Total Knee System; World Total Knee System?

The FDA product code for Active-V Total Knee System; World Total Knee System is MBH.

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Fonte oficial

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