FDA 510(k)

ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System

N.º K: K242734 · 2024-11-07

SolicitanteZsfab

Fecha de decisión2024-11-07

Código de productoODP

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Zsfab. It received FDA 510(k) clearance on 2024-11-07 under 510(k) number K242734. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System?

ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System is a medical device that received FDA 510(k) clearance on 2024-11-07. The listed applicant is Zsfab. The 510(k) number is K242734.

When did ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System receive FDA 510(k) clearance?

ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System received FDA 510(k) clearance on 2024-11-07, under 510(k) number K242734.

Who is the listed applicant for ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System?

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

What is the FDA product code for ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System?

The FDA product code for ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System is ODP.

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Dispositivos relacionados (Código: ODP)

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Fuente oficial

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