FDA 510(k)

Virata Spinal Fixation System

N.º K: K250908 · 2025-06-18

SolicitanteSeaSpine Orthopedics Corporation

Fecha de decisión2025-06-18

Código de productoNKB

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Virata Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2025-06-18 under 510(k) number K250908. 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 Virata Spinal Fixation System?

Virata Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2025-06-18. The listed applicant is SeaSpine Orthopedics Corporation. The 510(k) number is K250908.

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

Virata Spinal Fixation System received FDA 510(k) clearance on 2025-06-18, under 510(k) number K250908.

Who is the listed applicant for Virata Spinal Fixation System?

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

What is the FDA product code for Virata Spinal Fixation System?

The FDA product code for Virata Spinal Fixation System is NKB.

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Otros registros que enlistan a SeaSpine Orthopedics Corporation como solicitante

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Fuente oficial

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