510(k) K051123

CALLOS IMPACT AND INJECT BONE VOID FILLER by Skeletal Kinetics, LLC — Product Code MQV

K051123 is an FDA 510(k) premarket notification submitted by Skeletal Kinetics, LLC for the device "CALLOS IMPACT AND INJECT BONE VOID FILLER". The FDA issued a decision of Substantially Equivalent on June 3, 2005. 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.