SYNTHES MEDIUM EXTERNAL FIXATION SYSTEM-MR SAFE

SYNTHES MEDIUM EXTERNAL FIXATION SYSTEM-MR SAFE is an FDA 510(k)-cleared medical device (K040258) 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 March 22, 2004. Regulation: 8.