FDA 510(k)

Frontier Medical Devices In-Line Orthopedic Cable Cerclage System

Numéro K : K153242 · 2016-01-13

Date de décision2016-01-13

Code produitJDQ

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Dispositifs connexes (Code : JDQ)

K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage SuturesArthrex, Inc.K232733Mbrace CableMedacta International S.A.K233949Système de câble ACCORDSmith & Nephew, Inc.K232986VariTrax Sternal CircumFixation SystemCircumfix Solutions, Inc.

Source officielle

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