510(k) K193479

Sternal Cable System by A & E Medical Corporation — Product Code JDQ

K193479 is an FDA 510(k) premarket notification submitted by A & E Medical Corporation for the device "Sternal Cable System". The FDA issued a decision of Substantially Equivalent on March 23, 2020. 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.