VERSALOK LOW BACK FIXATION SYSTEM

VERSALOK LOW BACK FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K992885) manufactured by Osteotech, 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 November 18, 1999. Regulation: 8.