LIMA 28MM CERAMIC HEAD, MODIFICATION

LIMA 28MM CERAMIC HEAD, MODIFICATION is an FDA 510(k)-cleared medical device (K912985) manufactured by Turnkey Intergration USA, 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 December 23, 1991. Regulation: 8.