510(k) K193083

M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System by Medacta International S.A. — Product Code OUR

K193083 is an FDA 510(k) premarket notification submitted by Medacta International S.A. for the device "M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System". The FDA issued a decision of Substantially Equivalent on Dec 3, 2019. The device falls under product code OUR (Sacroiliac Joint Fixation), a Class II device regulated under 21 CFR 888.3040. Medacta International S.A. has 207 other 510(k) clearances on record.