InCore® Lapidus Sterile Kits

InCore® Lapidus Sterile Kits is an FDA 510(k)-cleared medical device (K190231) manufactured by Nextremity Solutions, 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 May 23, 2019. Regulation: 8.