ONE-PIECE PEEK FUSION IMPLANT

ONE-PIECE PEEK FUSION IMPLANT is an FDA 510(k)-cleared medical device (K140970) manufactured by Mtp 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 May 12, 2014. Regulation: 8.