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FDA 510(k)

Frontier Medical Devices In-Line Orthopedic Cable Cerclage System

K-Number: K153242 · 2016-01-13

ApplicantFrontier Medical Devices, Inc.
Decision Date2016-01-13
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: JDQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.K233949ACCORD Cable SystemSmith & Nephew, Inc.K232986VariTrax Sternal CircumFixation SystemCircumfix Solutions, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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