Rotium Bioresorbable Wick

Rotium Bioresorbable Wick is an FDA 510(k)-cleared medical device (K201414) manufactured by Nanofiber Solutions, LLC. 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 24, 2020. Regulation: 8.