IGNITE Bone Void Filler

IGNITE Bone Void Filler is an FDA 510(k)-cleared medical device (K190482) 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 May 27, 2019. Regulation: 8.