ORTHOMET RESURFACING FEMORAL COMPONENT

ORTHOMET RESURFACING FEMORAL COMPONENT is an FDA 510(k)-cleared medical device (K944752) 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 December 27, 1994. Regulation: 8.