Thorecon™ Fixation System

Cerclage, Fixation

A&E Medical Corporation

The following data is part of a premarket notification filed by A&e Medical Corporation with the FDA for Thorecon™ Fixation System.

Pre-market Notification Details

• Device ID: K173579
• 510k Number: K173579
• Device Name: Thorecon™ Fixation System
• Classification: Cerclage, Fixation
• Applicant: A&E Medical Corporation 5206 Asbury Road, PO Box 758 Farmingdale, NJ 07727
• Contact: Dana Rodriguez
• Correspondent: Sarah Pleaugh; RTI Surgical Inc. 375 River Park Circle Marquette, MI 49855
• Product Code: JDQ
• Subsequent Product Code: GAQ
• Subsequent Product Code: HRS
• Subsequent Product Code: HWC
• CFR Regulation Number: 888.3010 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-11-20
• Decision Date: 2018-02-12
• Summary: summary