FDA 510(k)

Sistema de Plaque de Tíbia Airlock®

N.º K: K260274 · 2026-03-25

Fecha de decisión2026-03-25

Código de productoHRS

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Airlock® Ankle Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Novastep SAS. It received FDA 510(k) clearance on 2026-03-25 under 510(k) number K260274. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Airlock® Ankle Plating System?

Airlock® Ankle Plating System is a medical device that received FDA 510(k) clearance on 2026-03-25. The listed applicant is Novastep SAS. The 510(k) number is K260274.

When did Airlock® Ankle Plating System receive FDA 510(k) clearance?

Airlock® Ankle Plating System received FDA 510(k) clearance on 2026-03-25, under 510(k) number K260274.

Who is the listed applicant for Airlock® Ankle Plating System?

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

What is the FDA product code for Airlock® Ankle Plating System?

The FDA product code for Airlock® Ankle Plating System is HRS.

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Fuente oficial

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