NOILES(TM) TOTAL KNEE PROSTHESIS, MODIFICATION

NOILES(TM) TOTAL KNEE PROSTHESIS, MODIFICATION is an FDA 510(k)-cleared medical device (K905810) 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 June 11, 1991. Regulation: 8.