CALLOS IMPACT AND INJECT BONE VOID FILLER

CALLOS IMPACT AND INJECT BONE VOID FILLER is an FDA 510(k)-cleared medical device (K051123) manufactured by Skeletal Kinetics, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 2, 2005. Regulation: 8.