K-WIRES AND STEINMANN PINS

K-WIRES AND STEINMANN PINS is an FDA 510(k)-cleared medical device (K941434) manufactured by Omega Surgical Instruments, 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 October 2, 1994. Regulation: 8.