510(k) K042072

CALLOS CMF BONE VOID FILLER by Skeletal Kinetics, LLC — Product Code GXP

K042072 is an FDA 510(k) premarket notification submitted by Skeletal Kinetics, LLC for the device "CALLOS CMF BONE VOID FILLER". The FDA issued a decision of Substantially Equivalent on September 16, 2004. The device falls under product code GXP (Methyl Methacrylate For Cranioplasty), a Class II device regulated under 21 CFR 882.5300. Skeletal Kinetics, LLC has at least 9 other 510(k) clearances on record.