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Highgate Orthopaedics
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MODIFICATION TO HIGHGATE CURVED ROD SYSTEM is an FDA 510(k)-cleared medical device (K023983) manufactured by Highgate Orthopaedics. 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 21, 2003. Regulation: 8.