Ultima HA Coated Half Pins and Wire

Ultima HA Coated Half Pins and Wire is an FDA 510(k)-cleared medical device (K163487) manufactured by Vilex IN Tennessee, 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 February 12, 2017. Regulation: 8.