First 510(k) Clearance for Customized 3D-Printed Polymeric Cranial Implants

Posted Leave a commentPosted in Medical and Dental, Rapid Prototyping

Oxford Performance Materials (OPM), South Windsor, Conn., made medical history in February when they received the first Food and Drug Administration (FDA) 510(k) clearance for their polymer laser-sintered OsteoFab Patient-Specific Cranial Device (OPSCD). The customizable implant is designed to restore voids in the skull caused by trauma or disease. Manufactured in a matter of hours […]