TRACERS BONE CEMENT OPACIFIER

TRACERS BONE CEMENT OPACIFIER is an FDA 510(k)-cleared medical device (K023445) manufactured by Parallax Medical, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 10, 2003. Regulation: 8.