FDA 510(k)

OsteoCNX

N.º K: K223563 · 2023-01-25

Fecha de decisión2023-01-25

Código de productoMQV

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

OsteoCNX is the device name listed in this FDA 510(k) record. The listed applicant is Converg Engineering. It received FDA 510(k) clearance on 2023-01-25 under 510(k) number K223563. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the OsteoCNX?

OsteoCNX is a medical device that received FDA 510(k) clearance on 2023-01-25. The listed applicant is Converg Engineering. The 510(k) number is K223563.

When did OsteoCNX receive FDA 510(k) clearance?

OsteoCNX received FDA 510(k) clearance on 2023-01-25, under 510(k) number K223563.

Who is the listed applicant for OsteoCNX?

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

What is the FDA product code for OsteoCNX?

The FDA product code for OsteoCNX is MQV.

Ensayos clínicos relacionados

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Dispositivos relacionados (Código: MQV)

Fuente oficial

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