FDA 510(k)

Citregen Tendon Interference Screw and Citrelock

Номер K: K200725 · 2020-10-07

Дата решения2020-10-07

Код продуктаMAI

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

Citregen Tendon Interference Screw and Citrelock is the device name listed in this FDA 510(k) record. The listed applicant is Acuitive Technologies. It received FDA 510(k) clearance on 2020-10-07 under 510(k) number K200725. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Citregen Tendon Interference Screw and Citrelock?

Citregen Tendon Interference Screw and Citrelock is a medical device that received FDA 510(k) clearance on 2020-10-07. The listed applicant is Acuitive Technologies. The 510(k) number is K200725.

When did Citregen Tendon Interference Screw and Citrelock receive FDA 510(k) clearance?

Citregen Tendon Interference Screw and Citrelock received FDA 510(k) clearance on 2020-10-07, under 510(k) number K200725.

Who is the listed applicant for Citregen Tendon Interference Screw and Citrelock?

The FDA 510(k) record lists Acuitive Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Citregen Tendon Interference Screw and Citrelock?

The FDA product code for Citregen Tendon Interference Screw and Citrelock is MAI.

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: MAI)

K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.K260294SF Push-in AnchorSurgical Fusion Technologies GmbH K254055OSSIOfiber® Suture AnchorOSSIO , Ltd.K251680Biosteon® ScrewBiocomposites, Ltd.K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation

Официальный источник

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