Seneka I Polyscrew Pedicle Fixation System

Seneka I Polyscrew Pedicle Fixation System is an FDA 510(k)-cleared medical device (K151849) manufactured by Senecka Spine. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 29, 2015. Regulation: 8.