Wrist Hemiarthroplasty System

Wrist Hemiarthroplasty System is an FDA 510(k)-cleared medical device (K141920) 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 December 22, 2014. Regulation: 8.