BTI CORTICAL BONE SCREWS

BTI CORTICAL BONE SCREWS is an FDA 510(k)-cleared medical device (K972403) manufactured by Biodynamic 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 August 28, 1997. Regulation: 8.