5.0MM SPINAL SCREWS

5.0MM SPINAL SCREWS is an FDA 510(k)-cleared medical device (K994288) manufactured by Ortho Tec, LLC. 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 9, 2000. Regulation: 8.