MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEM

MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEM is an FDA 510(k)-cleared medical device (K990745) manufactured by Synthes Spine. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 29, 1999. Regulation: 8.