
Australian Surgical Design & Manufacture
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ACTIVE UNICOMPARTMENTAL KNEE SYSTEM is an FDA 510(k)-cleared medical device (K060412) manufactured by Australian Surgical Design & Manufacture. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 16, 2006. Regulation: 8.