Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System

Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System is an FDA 510(k)-cleared medical device (K192818) manufactured by Stryker Corporation. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 30, 2020. Regulation: 8.