MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR

MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR is an FDA 510(k)-cleared medical device (K991528) manufactured by Danek 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 27, 1999. Regulation: 8.