FDA 510(k)

OR3O Dual Mobility System

N.º K: K242375 · 2024-10-07

Fecha de decisión2024-10-07

Código de productoLPH

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Fuente oficial

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