PRIME CEMENTED SMALL FEMORAL STEM

PRIME CEMENTED SMALL FEMORAL STEM is an FDA 510(k)-cleared medical device (K953033) manufactured by Orthopaedic Innovations, 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 September 12, 1995. Regulation: 8.