510(k) K133809

OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE by Oxford Performance Materials — Product Code KKY

K133809 is an FDA 510(k) premarket notification submitted by Oxford Performance Materials for the device "OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE". The FDA issued a decision of Substantially Equivalent on July 28, 2014. 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 has at least 5 other 510(k) clearances on record.