
Skeletal Kinetics, LLC
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CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLER is an FDA 510(k)-cleared medical device (K112383) 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 February 6, 2012. Regulation: 8.