Cannulated Screw — 510(k) da FDA K161058

Resumo do dispositivo

Cannulated Screw is the device name listed in this FDA 510(k) record. The listed applicant is Miami Device Solutions, LLC. It received FDA 510(k) clearance on 2016-07-29 under 510(k) number K161058. 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.

Perguntas frequentes

What is the Cannulated Screw?

Cannulated Screw is a medical device that received FDA 510(k) clearance on 2016-07-29. The listed applicant is Miami Device Solutions, LLC. The 510(k) number is K161058.

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

Cannulated Screw received FDA 510(k) clearance on 2016-07-29, under 510(k) number K161058.

Who is the listed applicant for Cannulated Screw?

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

What is the FDA product code for Cannulated Screw?

The FDA product code for Cannulated Screw is HWC. This falls under the Cardiovascular category.

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Outros registros que listam Miami Device Solutions, LLC como candidato(a)

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Dispositivos Relacionados (Código: HWC)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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.

Fonte oficial

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