CALTRIX RESORBABLE BONE VOID FILLER

CALTRIX RESORBABLE BONE VOID FILLER is an FDA 510(k)-cleared medical device (K083279) manufactured by Ag Digital Technology Corp.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 27, 2009. Regulation: 8.