OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE

OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE is an FDA 510(k)-cleared medical device (K043420) manufactured by Regeneration Technologies, 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 February 9, 2005. Regulation: 8.