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FDA 510(k)

Clavicle and Scapula System

N.º K: K240181 · 2024-10-09

SolicitanteAuxein Medical Pvt., Ltd.
Fecha de decisión2024-10-09
Código de productoHRS
Comité asesorOR
DecisiónSubstantially Equivalent

Resumen del dispositivo

Clavicle and Scapula System is the device name listed in this FDA 510(k) record. The listed applicant is Auxein Medical Pvt., Ltd.. It received FDA 510(k) clearance on 2024-10-09 under 510(k) number K240181. 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 Clavicle and Scapula System?

Clavicle and Scapula System is a medical device that received FDA 510(k) clearance on 2024-10-09. The listed applicant is Auxein Medical Pvt., Ltd.. The 510(k) number is K240181.

When did Clavicle and Scapula System receive FDA 510(k) clearance?

Clavicle and Scapula System received FDA 510(k) clearance on 2024-10-09, under 510(k) number K240181.

Who is the listed applicant for Clavicle and Scapula System?

The FDA 510(k) record lists Auxein Medical Pvt., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Clavicle and Scapula System?

The FDA product code for Clavicle and Scapula System is HRS.

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Fuente oficial

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