LESSER METATARSAL HEAD IMPLANT SYSTEM

LESSER METATARSAL HEAD IMPLANT SYSTEM is an FDA 510(k)-cleared medical device (K131187) manufactured by Solana Surgical, 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 October 21, 2013. Regulation: 8.