S-ROM(TM)/NOILES(TM) MARK 5 KNEE

S-ROM(TM)/NOILES(TM) MARK 5 KNEE is an FDA 510(k)-cleared medical device (K896397) 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 February 21, 1990. Regulation: 8.