THE UNIVERSAL BONE CEMENT RESISTOR

THE UNIVERSAL BONE CEMENT RESISTOR is an FDA 510(k)-cleared medical device (K924323) manufactured by Biodynamic Technologies, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 11, 1993. Regulation: 8.