TRAUMACEM™ V+ Injectable Bone Cement

TRAUMACEM™ V+ Injectable Bone Cement is an FDA 510(k)-cleared medical device (K170802) manufactured by Synthes (USA) Products, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 27, 2017. Regulation: 8.