MedCAD AccuShape Titanium Patient-Specific Cranial Implant

MedCAD AccuShape Titanium Patient-Specific Cranial Implant is an FDA 510(k)-cleared medical device (K220357) manufactured by Medcad. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 25, 2022. Regulation: 8.