French implant developer Medicrea has filed a 510(k) submission for U.S. Food and Drug Administration (FDA) clearance of its 3D-printed titanium patient-specific spinal implant.
The device is compatible with Medicrea's UNiD Lab personalized surgical planning and analytical services, the firm added. UNiD Lab services enable surgeons preoperatively to define exact 3D-printed interbody anatomical specifications that are matched with a predictive analysis of global spinal alignment parameters.
