enHAnce PEEK Bunion System

enHAnce PEEK Bunion System is an FDA 510(k)-cleared medical device (K253718) manufactured by Nvision Biomedical Technologies, 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 31, 2026. Regulation: 8.