FDA 510(k)

Sistema de Quadril Simétrico™ Total Agility

Número K: K242412 · 2024-11-06

Data da decisão2024-11-06

Código do produtoMBH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Agility Symmetric™ Total Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Medisurge, LLC. It received FDA 510(k) clearance on 2024-11-06 under 510(k) number K242412. 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 Agility Symmetric™ Total Knee System?

Agility Symmetric™ Total Knee System is a medical device that received FDA 510(k) clearance on 2024-11-06. The listed applicant is Medisurge, LLC. The 510(k) number is K242412.

When did Agility Symmetric™ Total Knee System receive FDA 510(k) clearance?

Agility Symmetric™ Total Knee System received FDA 510(k) clearance on 2024-11-06, under 510(k) number K242412.

Who is the listed applicant for Agility Symmetric™ Total Knee System?

The FDA 510(k) record lists Medisurge, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Agility Symmetric™ Total Knee System?

The FDA product code for Agility Symmetric™ Total Knee System is MBH.

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Dispositivos Relacionados (Código: MBH)

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Fonte oficial

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