OTI BONE CEMENT PLUG

OTI BONE CEMENT PLUG is an FDA 510(k)-cleared medical device (K030608) manufactured by Osteoimplant Technology, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 11, 2003. Regulation: 8.