UNI-ROM TOTAL HIP SYSTEM FEMORAL STEM

UNI-ROM TOTAL HIP SYSTEM FEMORAL STEM is an FDA 510(k)-cleared medical device (K974331) manufactured by Johnson & Johnson Professionals, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 5, 1998. Regulation: 8.