TITANIUM NITRIDE COATED HEMI-HEAD COMPONENT

TITANIUM NITRIDE COATED HEMI-HEAD COMPONENT is an FDA 510(k)-cleared medical device (K924050) manufactured by Orthomet, 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 August 24, 1993. Regulation: 8.