AFX Femoral Implant with Inserter

AFX Femoral Implant with Inserter is an FDA 510(k)-cleared medical device (K192428) manufactured by Cayenne 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 October 4, 2019. Regulation: 8.