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FDA 510(k)

ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER)

K-Number: K102834 · 2011-01-12

ApplicantKinamed, Incorporated
Decision Date2011-01-12
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER) is the device name listed in this FDA 510(k) record. The listed applicant is Kinamed, Incorporated. It received FDA 510(k) clearance on 2011-01-12 under 510(k) number K102834. 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 ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER)?

ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER) is a medical device that received FDA 510(k) clearance on 2011-01-12. The listed applicant is Kinamed, Incorporated. The 510(k) number is K102834.

When did ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER) receive FDA 510(k) clearance?

ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER) received FDA 510(k) clearance on 2011-01-12, under 510(k) number K102834.

Who is the listed applicant for ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER)?

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

What is the FDA product code for ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER)?

The FDA product code for ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER) is JDQ.

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Other records listing Kinamed, Incorporated as applicant

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.

K181749SuperCable® Iso-Elastic™ Cerclage System

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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