FDA 510(k)

ExsoMed ITN Cannulated Screw System

Номер K: K171558 · 2017-09-01

Дата решения2017-09-01

Код продуктаHWC

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

ExsoMed ITN Cannulated Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Exsomed Holdings Company, LLC. It received FDA 510(k) clearance on 2017-09-01 under 510(k) number K171558. 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 ExsoMed ITN Cannulated Screw System?

ExsoMed ITN Cannulated Screw System is a medical device that received FDA 510(k) clearance on 2017-09-01. The listed applicant is Exsomed Holdings Company, LLC. The 510(k) number is K171558.

When did ExsoMed ITN Cannulated Screw System receive FDA 510(k) clearance?

ExsoMed ITN Cannulated Screw System received FDA 510(k) clearance on 2017-09-01, under 510(k) number K171558.

Who is the listed applicant for ExsoMed ITN Cannulated Screw System?

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

What is the FDA product code for ExsoMed ITN Cannulated Screw System?

The FDA product code for ExsoMed ITN Cannulated Screw System 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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