SYNTHES STERILE PINLESS EXTERNAL FIXATOR

SYNTHES STERILE PINLESS EXTERNAL FIXATOR is an FDA 510(k)-cleared medical device (K925460) 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 9, 1994. Regulation: 8.