510(k) K100986

CALLOS BONE VOID FILLER, SKAFFOLD NEXT GENERATION BONE VOID FILLER, OSTEO VATION by Skeletal Kinetics, LLC — Product Code MQV

K100986 is an FDA 510(k) premarket notification submitted by Skeletal Kinetics, LLC for the device "CALLOS BONE VOID FILLER, SKAFFOLD NEXT GENERATION BONE VOID FILLER, OSTEO VATION". The FDA issued a decision of Substantially Equivalent on July 20, 2010. 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.