Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System

Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System is an FDA 510(k)-cleared medical device (K180078) manufactured by Innovasis, 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 April 16, 2018. Regulation: 8.