TRIFIX PEDICLE SPINAL SCREW ASSEMBLY

TRIFIX PEDICLE SPINAL SCREW ASSEMBLY is an FDA 510(k)-cleared medical device (K990657) manufactured by Corin USA. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 25, 1999. Regulation: 8.