510(k) K112383

CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLER by Skeletal Kinetics, LLC — Product Code MQV

K112383 is an FDA 510(k) premarket notification submitted by Skeletal Kinetics, LLC for the device "CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLER". The FDA issued a decision of Substantially Equivalent on February 7, 2012. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Skeletal Kinetics, LLC has at least 9 other 510(k) clearances on record.