
Scandius Biomedical, Inc.
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SCANDIUS ACL RECONSTRUCTION SYSTEM is an FDA 510(k)-cleared medical device (K041749) manufactured by Scandius Biomedical, 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 7, 2004. Regulation: 8.