FDA 510(k)

Auxilock Titanium Interference Screw

Número K: K203029 · 2021-08-20

RequerenteAuxein Medical Private Limited

Data da decisão2021-08-20

Código do produtoHWC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Auxilock Titanium Interference Screw 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 2021-08-20 under 510(k) number K203029. 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 Auxilock Titanium Interference Screw?

Auxilock Titanium Interference Screw is a medical device that received FDA 510(k) clearance on 2021-08-20. The listed applicant is Auxein Medical Private Limited. The 510(k) number is K203029.

When did Auxilock Titanium Interference Screw receive FDA 510(k) clearance?

Auxilock Titanium Interference Screw received FDA 510(k) clearance on 2021-08-20, under 510(k) number K203029.

Who is the listed applicant for Auxilock Titanium Interference Screw?

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 Auxilock Titanium Interference Screw?

The FDA product code for Auxilock Titanium Interference Screw is HWC. This falls under the Cardiovascular category.

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Outros registros que listam Auxein Medical Private Limited como candidato(a)

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Fonte oficial

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