FDA 510(k)

Regeneten Bioinductive Implant

N.º K: K222501 · 2023-05-11

Fecha de decisión2023-05-11

Código de productoOWY

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Regeneten Bioinductive Implant is the device name listed in this FDA 510(k) record. The listed applicant is Smith and Nephew, Inc.. It received FDA 510(k) clearance on 2023-05-11 under 510(k) number K222501. The device is classified under product code OWY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Regeneten Bioinductive Implant?

Regeneten Bioinductive Implant is a medical device that received FDA 510(k) clearance on 2023-05-11. The listed applicant is Smith and Nephew, Inc.. The 510(k) number is K222501.

When did Regeneten Bioinductive Implant receive FDA 510(k) clearance?

Regeneten Bioinductive Implant received FDA 510(k) clearance on 2023-05-11, under 510(k) number K222501.

Who is the listed applicant for Regeneten Bioinductive Implant?

The FDA 510(k) record lists Smith and Nephew, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Regeneten Bioinductive Implant?

The FDA product code for Regeneten Bioinductive Implant is OWY.

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Otros registros que enlistan a Smith and Nephew, Inc. como solicitante

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Ver todos los 112 dispositivos →

Dispositivos relacionados (Código: OWY)

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.