510(k) K051784

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

K051784 is an FDA 510(k) premarket notification submitted by Skeletal Kinetics, LLC for the device "OSTEOVATION CMF BONE VOID FILLER". The FDA issued a decision of Substantially Equivalent on July 20, 2005. 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.