510(k) K232733

Mbrace Cable by Medacta International S.A. — Product Code JDQ

K232733 is an FDA 510(k) premarket notification submitted by Medacta International S.A. for the device "Mbrace Cable". The FDA issued a decision of Substantially Equivalent on May 3, 2024. The device falls under product code JDQ (Cerclage, Fixation), a Class II device regulated under 21 CFR 888.3010. Medacta International S.A. has at least 10 other 510(k) clearances on record.