
Implex Corp.
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THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0 is an FDA 510(k)-cleared medical device (K012866) manufactured by Implex Corp.. 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 25, 2001. Regulation: 8.