
Synthes (Usa)
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SYNTHES LCP PROXIMAL TIBIA PLATE is an FDA 510(k)-cleared medical device (K011978) manufactured by Synthes (Usa). This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 8, 2001. Regulation: 8.