FDA 510(k)

Cortera™ Spinal Fixation System

N.º K: K241892 · 2024-08-02

Fecha de decisión2024-08-02

Código de productoNKB

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Cortera™ Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Xtant Medical Holdings, Inc.. It received FDA 510(k) clearance on 2024-08-02 under 510(k) number K241892. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Cortera™ Spinal Fixation System?

Cortera™ Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2024-08-02. The listed applicant is Xtant Medical Holdings, Inc.. The 510(k) number is K241892.

When did Cortera™ Spinal Fixation System receive FDA 510(k) clearance?

Cortera™ Spinal Fixation System received FDA 510(k) clearance on 2024-08-02, under 510(k) number K241892.

Who is the listed applicant for Cortera™ Spinal Fixation System?

The FDA 510(k) record lists Xtant Medical Holdings, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cortera™ Spinal Fixation System?

The FDA product code for Cortera™ Spinal Fixation System is NKB.

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Fuente oficial

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