510(k) K161052

OsteoFab Patient Specific Facial Device by Oxford Performance Materials, Inc. — Product Code KKY

K161052 is an FDA 510(k) premarket notification submitted by Oxford Performance Materials, Inc. for the device "OsteoFab Patient Specific Facial Device". The FDA issued a decision of Substantially Equivalent on July 20, 2016. The device falls under product code KKY (Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction), a Class II device regulated under 21 CFR 878.3500. Oxford Performance Materials, Inc. has at least 5 other 510(k) clearances on record.