FDA 510(k)

EUROSCREW NG; EUROSCREW TCP NG

Номер K: K230394 · 2023-05-12

ЗаявительTeknimed

Дата решения2023-05-12

Код продуктаMAI

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

EUROSCREW NG; EUROSCREW TCP NG is the device name listed in this FDA 510(k) record. The listed applicant is Teknimed. It received FDA 510(k) clearance on 2023-05-12 under 510(k) number K230394. 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 EUROSCREW NG; EUROSCREW TCP NG?

EUROSCREW NG; EUROSCREW TCP NG is a medical device that received FDA 510(k) clearance on 2023-05-12. The listed applicant is Teknimed. The 510(k) number is K230394.

When did EUROSCREW NG; EUROSCREW TCP NG receive FDA 510(k) clearance?

EUROSCREW NG; EUROSCREW TCP NG received FDA 510(k) clearance on 2023-05-12, under 510(k) number K230394.

Who is the listed applicant for EUROSCREW NG; EUROSCREW TCP NG?

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

What is the FDA product code for EUROSCREW NG; EUROSCREW TCP NG?

The FDA product code for EUROSCREW NG; EUROSCREW TCP NG 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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