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United States Surgical, A Division of Tyco Healthc
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SPIRAL RADIUS RODDING SYSTEM is an FDA 510(k)-cleared medical device (K000009) manufactured by United States Surgical, A Division of Tyco Healthc. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 9, 2000. Regulation: 8.