FDA 510(k)

Clavicle and Scapula System

Número K: K240181 · 2024-10-09

Data da decisão2024-10-09

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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