510(k) K252885

OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System by Astura Medical — Product Code PML

K252885 is an FDA 510(k) premarket notification submitted by Astura Medical for the device "OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System". The FDA issued a decision of Substantially Equivalent on January 22, 2026. The device falls under product code PML (Bone Cement, Posterior Screw Augmentation), a Class II device regulated under 21 CFR 888.3027. Astura Medical has at least 10 other 510(k) clearances on record.