FDA 510(k)

OrthoSolutions 'System26' Bone Screws

Номер K: K163489 · 2017-03-08

Дата решения2017-03-08

Код продуктаHWC

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

OrthoSolutions 'System26' Bone Screws is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Solutions UK Limited. It received FDA 510(k) clearance on 2017-03-08 under 510(k) number K163489. 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 OrthoSolutions 'System26' Bone Screws?

OrthoSolutions 'System26' Bone Screws is a medical device that received FDA 510(k) clearance on 2017-03-08. The listed applicant is Ortho Solutions UK Limited. The 510(k) number is K163489.

When did OrthoSolutions 'System26' Bone Screws receive FDA 510(k) clearance?

OrthoSolutions 'System26' Bone Screws received FDA 510(k) clearance on 2017-03-08, under 510(k) number K163489.

Who is the listed applicant for OrthoSolutions 'System26' Bone Screws?

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

What is the FDA product code for OrthoSolutions 'System26' Bone Screws?

The FDA product code for OrthoSolutions 'System26' Bone Screws 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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