HEIDELBERG EXTERNAL FIXATOR

HEIDELBERG EXTERNAL FIXATOR is an FDA 510(k)-cleared medical device (K970751) manufactured by Smith & Nephew, Inc., Orthopaedic Div.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 15, 1997. Regulation: 8.