SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM

SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM is an FDA 510(k)-cleared medical device (K094002) manufactured by Spartek Medical, 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 May 6, 2010. Regulation: 8.