FDA 510(k)

S4 Screw System™

Номер K: K162171 · 2017-09-07

Дата решения2017-09-07

Код продуктаHWC

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

S4 Screw System™ is the device name listed in this FDA 510(k) record. The listed applicant is Subchondral Solutions. It received FDA 510(k) clearance on 2017-09-07 under 510(k) number K162171. 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 S4 Screw System™?

S4 Screw System™ is a medical device that received FDA 510(k) clearance on 2017-09-07. The listed applicant is Subchondral Solutions. The 510(k) number is K162171.

When did S4 Screw System™ receive FDA 510(k) clearance?

S4 Screw System™ received FDA 510(k) clearance on 2017-09-07, under 510(k) number K162171.

Who is the listed applicant for S4 Screw System™?

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

What is the FDA product code for S4 Screw System™?

The FDA product code for S4 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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