FDA 510(k)

Auxein Nailing System

Número K: K210792 · 2021-08-25

RequerenteAuxein Medical Private Limited

Data da decisão2021-08-25

Código do produtoHWC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Auxein Nailing System is the device name listed in this FDA 510(k) record. The listed applicant is Auxein Medical Private Limited. It received FDA 510(k) clearance on 2021-08-25 under 510(k) number K210792. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Auxein Nailing System?

Auxein Nailing System is a medical device that received FDA 510(k) clearance on 2021-08-25. The listed applicant is Auxein Medical Private Limited. The 510(k) number is K210792.

When did Auxein Nailing System receive FDA 510(k) clearance?

Auxein Nailing System received FDA 510(k) clearance on 2021-08-25, under 510(k) number K210792.

Who is the listed applicant for Auxein Nailing System?

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

What is the FDA product code for Auxein Nailing System?

The FDA product code for Auxein Nailing System is HWC. This falls under the Cardiovascular category.

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Fonte oficial

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