FDA 510(k)

Spinery™ RF Ablation System

N.º K: K223303 · 2023-08-30

Fecha de decisión2023-08-30

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Spinery™ RF Ablation System is the device name listed in this FDA 510(k) record. The listed applicant is Axon Spine Medical System. It received FDA 510(k) clearance on 2023-08-30 under 510(k) number K223303. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Spinery™ RF Ablation System?

Spinery™ RF Ablation System is a medical device that received FDA 510(k) clearance on 2023-08-30. The listed applicant is Axon Spine Medical System. The 510(k) number is K223303.

When did Spinery™ RF Ablation System receive FDA 510(k) clearance?

Spinery™ RF Ablation System received FDA 510(k) clearance on 2023-08-30, under 510(k) number K223303.

Who is the listed applicant for Spinery™ RF Ablation System?

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

What is the FDA product code for Spinery™ RF Ablation System?

The FDA product code for Spinery™ RF Ablation System is GEI.

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