FDA 510(k)

RetroFix

Número K: K200226 · 2020-06-26

Data da decisão2020-06-26

Código do produtoHWC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

RetroFix is the device name listed in this FDA 510(k) record. The listed applicant is Retrofix Screws, LLC. It received FDA 510(k) clearance on 2020-06-26 under 510(k) number K200226. 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 RetroFix?

RetroFix is a medical device that received FDA 510(k) clearance on 2020-06-26. The listed applicant is Retrofix Screws, LLC. The 510(k) number is K200226.

When did RetroFix receive FDA 510(k) clearance?

RetroFix received FDA 510(k) clearance on 2020-06-26, under 510(k) number K200226.

Who is the listed applicant for RetroFix?

The FDA 510(k) record lists Retrofix Screws, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RetroFix?

The FDA product code for RetroFix is HWC. This falls under the Cardiovascular category.

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Fonte oficial

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