IGNITE BONE VOID FILLER KIT

IGNITE BONE VOID FILLER KIT is an FDA 510(k)-cleared medical device (K052913) manufactured by Wrightmedicaltechnologyinc. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 6, 2005. Regulation: 8.