
Bionix Development Corp.
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THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010 is an FDA 510(k)-cleared medical device (K050701) manufactured by Bionix Development Corp.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 31, 2005. Regulation: 8.