POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX

POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX is an FDA 510(k)-cleared medical device (K033707) manufactured by Osteobiologics, 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 15, 2004. Regulation: 8.