FDA 510(k)

OR3O Dual Mobility System

Número K: K242375 · 2024-10-07

Data da decisão2024-10-07

Código do produtoLPH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

OR3O Dual Mobility 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 2024-10-07 under 510(k) number K242375. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the OR3O Dual Mobility System?

OR3O Dual Mobility System is a medical device that received FDA 510(k) clearance on 2024-10-07. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K242375.

When did OR3O Dual Mobility System receive FDA 510(k) clearance?

OR3O Dual Mobility System received FDA 510(k) clearance on 2024-10-07, under 510(k) number K242375.

Who is the listed applicant for OR3O Dual Mobility 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 OR3O Dual Mobility System?

The FDA product code for OR3O Dual Mobility System is LPH.

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