FDA 510(k)

Thorecon Fixation System

K-Number: K173579 · 2018-02-12

Decision Date2018-02-12

Product CodeJDQ

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Thorecon Fixation System is a medical device manufactured by A & E Medical Corporation. It received FDA 510(k) clearance on 2018-02-12 under approval number K173579. 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 Thorecon Fixation System?

Thorecon Fixation System is a medical device that received FDA 510(k) clearance on 2018-02-12. It is manufactured by A & E Medical Corporation. The 510(k) number is K173579.

When was Thorecon Fixation System approved by the FDA?

Thorecon Fixation System received FDA 510(k) clearance on 2018-02-12, under approval number K173579.

What company makes Thorecon Fixation System?

Thorecon Fixation System is manufactured by A & E Medical Corporation.

What is the FDA product code for Thorecon Fixation System?

The FDA product code for Thorecon Fixation System is JDQ.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07245719 Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up COMPLETED NCT07485829 Zimmer Biomet-RibFix Titan RECRUITING NCT07079774 TrueLok Elevate PMCF Study RECRUITING

Other Devices by A & E Medical Corporation

K181607Thorecon Rigid Fixation System K180582Sternal Cable System K193479Sternal Cable System

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.