Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SuperCable® Iso-Elastic™ Cerclage System

K-Number: K181749 · 2018-08-01

ApplicantKinamed, Incorporated
Decision Date2018-08-01
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SuperCable® Iso-Elastic™ Cerclage System is a medical device manufactured by Kinamed, Incorporated. It received FDA 510(k) clearance on 2018-08-01 under approval number K181749. 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 SuperCable® Iso-Elastic™ Cerclage System?

SuperCable® Iso-Elastic™ Cerclage System is a medical device that received FDA 510(k) clearance on 2018-08-01. It is manufactured by Kinamed, Incorporated. The 510(k) number is K181749.

When was SuperCable® Iso-Elastic™ Cerclage System approved by the FDA?

SuperCable® Iso-Elastic™ Cerclage System received FDA 510(k) clearance on 2018-08-01, under approval number K181749.

What company makes SuperCable® Iso-Elastic™ Cerclage System?

SuperCable® Iso-Elastic™ Cerclage System is manufactured by Kinamed, Incorporated.

What is the FDA product code for SuperCable® Iso-Elastic™ Cerclage System?

The FDA product code for SuperCable® Iso-Elastic™ Cerclage System is JDQ.

Related Clinical Trials

NCT07603531 Assessment of the Efficacy of the Dynamic Decongestive System in the Maintenance Phase of Lower Limb Lymphedema NOT_YET_RECRUITING NCT07251881 SuperCable vs. Conventional Steel Wire for Closure After a Median Sternotomy NOT_YET_RECRUITING

Related Devices (Code: JDQ)

K161876Tritium® Sternal Cable Plate SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. K151983KLS Martin LSS Plating SystemKLS Martin L.P. K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemZimmer, Inc. K153242Frontier Medical Devices In-Line Orthopedic Cable Cerclage SystemFrontier Medical Devices, Inc. K170206Arthrex FiberTape CerclageArthrex, Inc. K181607Thorecon Rigid Fixation SystemA & E Medical Corporation

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.

↑