FDA 510(k)

Frontier Medical Devices In-Line Orthopedic Cable Cerclage System

Номер K: K153242 · 2016-01-13

Дата решения2016-01-13

Код продуктаJDQ

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

Frontier Medical Devices In-Line Orthopedic Cable Cerclage System is the device name listed in this FDA 510(k) record. The listed applicant is Frontier Medical Devices, Inc.. It received FDA 510(k) clearance on 2016-01-13 under 510(k) number K153242. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Frontier Medical Devices In-Line Orthopedic Cable Cerclage System?

Frontier Medical Devices In-Line Orthopedic Cable Cerclage System is a medical device that received FDA 510(k) clearance on 2016-01-13. The listed applicant is Frontier Medical Devices, Inc.. The 510(k) number is K153242.

When did Frontier Medical Devices In-Line Orthopedic Cable Cerclage System receive FDA 510(k) clearance?

Frontier Medical Devices In-Line Orthopedic Cable Cerclage System received FDA 510(k) clearance on 2016-01-13, under 510(k) number K153242.

Who is the listed applicant for Frontier Medical Devices In-Line Orthopedic Cable Cerclage System?

The FDA 510(k) record lists Frontier Medical Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Frontier Medical Devices In-Line Orthopedic Cable Cerclage System?

The FDA product code for Frontier Medical Devices In-Line Orthopedic Cable Cerclage System is JDQ.

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: JDQ)

K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.K243344Arthrex FiberTape и TigerTape Cerclage Сutures; Arthrex Radiopaque FiberTape Cerclage СuturesArthrex, Inc.K232733Mbrace CableMedacta International S.A.K233949ACCORD Кабельная СистемаSmith & Nephew, Inc.K232986VariTrax Sternal CircumFixation SystemCircumfix Solutions, Inc.

Официальный источник

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