FDA 510K clearance Archives - 3D Printing Industry

The VSP PEEK Cranial Implant is the first FDA-cleared, additively manufactured PEEK implant intended for cranioplasty procedures to restore defects in the skull. Photo via 3D Systems.

3D Systems secures FDA clearance for its PEEK cranial implants

3D printer manufacturer 3D Systems has secured FDA 510K clearance for its 3D printed, patient-specific VSP polyetheretherketone (PEEK) Cranial Implant solution. The VSP PEEK Cranial Implant’s ab…