KFX APPIANFX PEEK FEMORAL IMPLANT WITH INSERTER

KFX APPIANFX PEEK FEMORAL IMPLANT WITH INSERTER is an FDA 510(k)-cleared medical device (K101175) manufactured by Kfx 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 May 19, 2010. Regulation: 8.