FDA 510(k)

RetroFix

Номер K: K200226 · 2020-06-26

Дата решения2020-06-26

Код продуктаHWC

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: HWC)

K262975Arthrex Beaming SystemArthrex, Inc.K260995DynaNail Helix® Fixation SystemMedShape, Inc.K254280F.A.S.T ScrewSteps Ortho K261057ActivaScrew™ Cannulated COMBioretec, Ltd.K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower Orthoped K262344Large Compression ScrewsTriMed, Inc.

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