SABA-COOMBS MINI EXTERNAL FIXATOR

SABA-COOMBS MINI EXTERNAL FIXATOR is an FDA 510(k)-cleared medical device (K842343) manufactured by Zimmer, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 10, 1984. Regulation: 8.