EMPOWR Stem Extender, 50mm

EMPOWR Stem Extender, 50mm is an FDA 510(k)-cleared medical device (K230441) manufactured by Encore Medical, L.P Dba Enovis. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 16, 2023. Regulation: 8.