510(k) K181607

Thorecon Rigid Fixation System by A & E Medical Corporation — Product Code JDQ

K181607 is an FDA 510(k) premarket notification submitted by A & E Medical Corporation for the device "Thorecon Rigid Fixation System". The FDA issued a decision of Substantially Equivalent on October 12, 2018. The device falls under product code JDQ (Cerclage, Fixation), a Class II device regulated under 21 CFR 888.3010. A & E Medical Corporation has at least 3 other 510(k) clearances on record.