510(k) K180064

OsteoFab Patient Specific Cranial Device by Oxford Performance Materials, Inc. — Product Code GXN

K180064 is an FDA 510(k) premarket notification submitted by Oxford Performance Materials, Inc. for the device "OsteoFab Patient Specific Cranial Device". The FDA issued a decision of Substantially Equivalent on July 27, 2018. 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, Inc. has at least 5 other 510(k) clearances on record.