510(k) K072601

OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT by Osteosymbionics, LLC — Product Code GXP

K072601 is an FDA 510(k) premarket notification submitted by Osteosymbionics, LLC for the device "OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT". The FDA issued a decision of Substantially Equivalent on December 10, 2007. The device falls under product code GXP (Methyl Methacrylate For Cranioplasty), a Class II device regulated under 21 CFR 882.5300. Osteosymbionics, LLC has at least 3 other 510(k) clearances on record.