SYNTHES UNIVERSAL SPINE HOOK AND ROD FIXATION SYST

SYNTHES UNIVERSAL SPINE HOOK AND ROD FIXATION SYST is an FDA 510(k)-cleared medical device (K921948) manufactured by Synthes (Usa). This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 21, 1993. Regulation: 8.