FDA 510(k)

360CAS

N.º K: K213380 · 2022-01-11

SolicitanteKico Knee Innovation Company Pty Limited

Fecha de decisión2022-01-11

Código de productoOLO

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

360CAS is the device name listed in this FDA 510(k) record. The listed applicant is Kico Knee Innovation Company Pty Limited. It received FDA 510(k) clearance on 2022-01-11 under 510(k) number K213380. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the 360CAS?

360CAS is a medical device that received FDA 510(k) clearance on 2022-01-11. The listed applicant is Kico Knee Innovation Company Pty Limited. The 510(k) number is K213380.

When did 360CAS receive FDA 510(k) clearance?

360CAS received FDA 510(k) clearance on 2022-01-11, under 510(k) number K213380.

Who is the listed applicant for 360CAS?

The FDA 510(k) record lists Kico Knee Innovation Company Pty Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 360CAS?

The FDA product code for 360CAS is OLO.

Otros registros que enlistan a Kico Knee Innovation Company Pty Limited como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K243980Sistema de Navegación Quirúrgica ARVIS K223927360CAS K163405Sistema de Posicionamiento de Implantes 360KS

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Fuente oficial

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