OSTEO AUSTIN MOORE ENDOPROSTHESIS SYSTEM

OSTEO AUSTIN MOORE ENDOPROSTHESIS SYSTEM is an FDA 510(k)-cleared medical device (K974807) manufactured by Osteonics Corp.. 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 15, 1998. Regulation: 8.