FDA 510(k)

Zeta Cranial Navigation System

N.º K: K230661 · 2023-09-08

Fecha de decisión2023-09-08

Código de productoHAW

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Zeta Cranial Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Zeta Surgical. It received FDA 510(k) clearance on 2023-09-08 under 510(k) number K230661. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Zeta Cranial Navigation System?

Zeta Cranial Navigation System is a medical device that received FDA 510(k) clearance on 2023-09-08. The listed applicant is Zeta Surgical. The 510(k) number is K230661.

When did Zeta Cranial Navigation System receive FDA 510(k) clearance?

Zeta Cranial Navigation System received FDA 510(k) clearance on 2023-09-08, under 510(k) number K230661.

Who is the listed applicant for Zeta Cranial Navigation System?

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

What is the FDA product code for Zeta Cranial Navigation System?

The FDA product code for Zeta Cranial Navigation System is HAW.

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Dispositivos relacionados (Código: HAW)

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Fuente oficial

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