ULTIMAX DISTAL RADIAL (VOLAR) LOCKING PLATE SYSTEM

ULTIMAX DISTAL RADIAL (VOLAR) LOCKING PLATE SYSTEM is an FDA 510(k)-cleared medical device (K990481) 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 March 16, 1999. Regulation: 8.