FDA 510(k)

ChM 4.5mm Cortical screws

Número K: K210490 · 2021-10-05

Data da decisão2021-10-05

Código do produtoHWC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

ChM 4.5mm Cortical screws is the device name listed in this FDA 510(k) record. The listed applicant is Chm Sp. Z O.O.. It received FDA 510(k) clearance on 2021-10-05 under 510(k) number K210490. 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 ChM 4.5mm Cortical screws?

ChM 4.5mm Cortical screws is a medical device that received FDA 510(k) clearance on 2021-10-05. The listed applicant is Chm Sp. Z O.O.. The 510(k) number is K210490.

When did ChM 4.5mm Cortical screws receive FDA 510(k) clearance?

ChM 4.5mm Cortical screws received FDA 510(k) clearance on 2021-10-05, under 510(k) number K210490.

Who is the listed applicant for ChM 4.5mm Cortical screws?

The FDA 510(k) record lists Chm Sp. Z O.O. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ChM 4.5mm Cortical screws?

The FDA product code for ChM 4.5mm Cortical screws is HWC. This falls under the Cardiovascular category.

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