FDA 510(k)

FIXIT / ComposiTCP Threaded Anchor System

Номер K: K180960 · 2018-07-25

ЗаявительS.B.M. Sas Sciences For Bio Materials

Дата решения2018-07-25

Код продуктаMAI

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

FIXIT / ComposiTCP Threaded Anchor System is the device name listed in this FDA 510(k) record. The listed applicant is S.B.M. Sas Sciences For Bio Materials. It received FDA 510(k) clearance on 2018-07-25 under 510(k) number K180960. 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 FIXIT / ComposiTCP Threaded Anchor System?

FIXIT / ComposiTCP Threaded Anchor System is a medical device that received FDA 510(k) clearance on 2018-07-25. The listed applicant is S.B.M. Sas Sciences For Bio Materials. The 510(k) number is K180960.

When did FIXIT / ComposiTCP Threaded Anchor System receive FDA 510(k) clearance?

FIXIT / ComposiTCP Threaded Anchor System received FDA 510(k) clearance on 2018-07-25, under 510(k) number K180960.

Who is the listed applicant for FIXIT / ComposiTCP Threaded Anchor System?

The FDA 510(k) record lists S.B.M. Sas Sciences For Bio Materials as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FIXIT / ComposiTCP Threaded Anchor System?

The FDA product code for FIXIT / ComposiTCP Threaded Anchor System 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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