S-ROM(TM) TOTAL LHIP SYSTEM W/CERAMIC HEAD

S-ROM(TM) TOTAL LHIP SYSTEM W/CERAMIC HEAD is an FDA 510(k)-cleared medical device (K913231) manufactured by Joint Medical Products 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 December 19, 1991. Regulation: 8.