BIOPHASE IMPLANT MATERIAL

BIOPHASE IMPLANT MATERIAL is an FDA 510(k)-cleared medical device (K792329) manufactured by Richard'S Medical Equip., 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 January 22, 1980. Regulation: 8.