
Sulzermedica
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MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA is an FDA 510(k)-cleared medical device (K002324) manufactured by Sulzermedica. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 23, 2000. Regulation: 8.