510(k) K121818

OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE by Oxford Performance Materials — Product Code GXN

K121818 is an FDA 510(k) premarket notification submitted by Oxford Performance Materials for the device "OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE". The FDA issued a decision of Substantially Equivalent on February 7, 2013. The device falls under product code GXN (Plate, Cranioplasty, Preformed, Non-Alterable), a Class II device regulated under 21 CFR 882.5330. Oxford Performance Materials has at least 5 other 510(k) clearances on record.