SENTRY(TM) ANTERIOR/POSTERIOR SPINAL SYSTEMS

SENTRY(TM) ANTERIOR/POSTERIOR SPINAL SYSTEMS is an FDA 510(k)-cleared medical device (K936294) manufactured by Sofamor Danek Mfg., 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 December 18, 1995. Regulation: 8.