PINIT SMALL BONE FUSION SYSTEM

PINIT SMALL BONE FUSION SYSTEM is an FDA 510(k)-cleared medical device (K140617) manufactured by Arthrosurface, 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 April 24, 2014. Regulation: 8.