HERBERT ULNAR HEAD PROSTHESIS SYSTEM

HERBERT ULNAR HEAD PROSTHESIS SYSTEM is an FDA 510(k)-cleared medical device (K042902) manufactured by Stuckenbrock Medizintechnik GmbH. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 26, 2004. Regulation: 8.