
Tecres S.P.A.
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KIT MENDEC SPINE AND DELIVERY SYSTEM is an FDA 510(k)-cleared medical device (K062452) manufactured by Tecres S.P.A.. 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 20, 2006. Regulation: 8.