IMPLEX H-110 AND H-120 CEMENTED HIP STEM SYSTEM

IMPLEX H-110 AND H-120 CEMENTED HIP STEM SYSTEM is an FDA 510(k)-cleared medical device (K925348) manufactured by Implex Corp.. 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 11, 1993. Regulation: 8.