510(k) K192818

Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System by Stryker Corporation — Product Code PML

K192818 is an FDA 510(k) premarket notification submitted by Stryker Corporation for the device "Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System". The FDA issued a decision of Substantially Equivalent on March 31, 2020. The device falls under product code PML (Bone Cement, Posterior Screw Augmentation), a Class II device regulated under 21 CFR 888.3027. Stryker Corporation has at least 10 other 510(k) clearances on record.