510(k) K241034

Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System by Medacta International S.A. — Product Code PML

K241034 is an FDA 510(k) premarket notification submitted by Medacta International S.A. for the device "Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System". The FDA issued a decision of Substantially Equivalent on June 12, 2024. The device falls under product code PML (Bone Cement, Posterior Screw Augmentation), a Class II device regulated under 21 CFR 888.3027. Medacta International S.A. has at least 10 other 510(k) clearances on record.