DeGen Medical Patient Specific Implant (PSI) System

DeGen Medical Patient Specific Implant (PSI) System is an FDA 510(k)-cleared medical device (K250667) manufactured by Degen Medical. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 3, 2025. Regulation: 8.