PROFYLE TITANIUM HAND AND SMALL FRAGMENT SYSTEM

PROFYLE TITANIUM HAND AND SMALL FRAGMENT SYSTEM is an FDA 510(k)-cleared medical device (K961497) manufactured by Howmedica, 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 June 27, 1996. Regulation: 8.