
K2m, Inc.
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PYRENEES CERVICAL PLATE SYSTEM, SEMI-CONSTRAINED SCREWS is an FDA 510(k)-cleared medical device (K092474) manufactured by K2m, Inc.. 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 10, 2010. Regulation: 8.