510(k) K231809

Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement by Ulrich Medical USA — Product Code PML

K231809 is an FDA 510(k) premarket notification submitted by Ulrich Medical USA for the device "Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement". The FDA issued a decision of Substantially Equivalent on October 20, 2023. The device falls under product code PML (Bone Cement, Posterior Screw Augmentation), a Class II device regulated under 21 CFR 888.3027. Ulrich Medical USA has at least 10 other 510(k) clearances on record.