FDA 510(k)

MultiFIX S Ultra Knotless Fixation System

Номер K: K153669 · 2016-01-19

Дата решения2016-01-19

Код продуктаMBI

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

MultiFIX S Ultra Knotless Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Arthocare Corporation. It received FDA 510(k) clearance on 2016-01-19 under 510(k) number K153669. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the MultiFIX S Ultra Knotless Fixation System?

MultiFIX S Ultra Knotless Fixation System is a medical device that received FDA 510(k) clearance on 2016-01-19. The listed applicant is Arthocare Corporation. The 510(k) number is K153669.

When did MultiFIX S Ultra Knotless Fixation System receive FDA 510(k) clearance?

MultiFIX S Ultra Knotless Fixation System received FDA 510(k) clearance on 2016-01-19, under 510(k) number K153669.

Who is the listed applicant for MultiFIX S Ultra Knotless Fixation System?

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

What is the FDA product code for MultiFIX S Ultra Knotless Fixation System?

The FDA product code for MultiFIX S Ultra Knotless Fixation System is MBI.

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: MBI)

K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc.K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.K262809ArthroTAK набор для анкеров тениArthroTAK, LLC K262677Iconix Knotless TRiverpoint Medical K262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker Endoscopy

Официальный источник

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