ISOBAR SEMI-RIGID SPINAL SYSTEM

ISOBAR SEMI-RIGID SPINAL SYSTEM is an FDA 510(k)-cleared medical device (K991326) manufactured by Scien'Tx USA, 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 7, 1999. Regulation: 8.