PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150,

PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150, is an FDA 510(k)-cleared medical device (K000515) manufactured by Interpore Cross Intl.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 14, 2000. Regulation: 8.