Uni Knee Resurfacing System

Uni Knee Resurfacing System is an FDA 510(k)-cleared medical device (K221292) manufactured by Overture Resurfacing, 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 March 9, 2023. Regulation: 8.