FDA 510(k)

Diamond Orthopedic Bone Fixation Screws and Pins

Номер K: K180932 · 2018-05-09

Дата решения2018-05-09

Код продуктаHWC

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

Diamond Orthopedic Bone Fixation Screws and Pins is the device name listed in this FDA 510(k) record. The listed applicant is Diamond Orthopedic, LLC. It received FDA 510(k) clearance on 2018-05-09 under 510(k) number K180932. 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 Diamond Orthopedic Bone Fixation Screws and Pins?

Diamond Orthopedic Bone Fixation Screws and Pins is a medical device that received FDA 510(k) clearance on 2018-05-09. The listed applicant is Diamond Orthopedic, LLC. The 510(k) number is K180932.

When did Diamond Orthopedic Bone Fixation Screws and Pins receive FDA 510(k) clearance?

Diamond Orthopedic Bone Fixation Screws and Pins received FDA 510(k) clearance on 2018-05-09, under 510(k) number K180932.

Who is the listed applicant for Diamond Orthopedic Bone Fixation Screws and Pins?

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

What is the FDA product code for Diamond Orthopedic Bone Fixation Screws and Pins?

The FDA product code for Diamond Orthopedic Bone Fixation Screws and Pins 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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