
K2m, Inc.
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THORACOLUMBAR, LUMBAR AND SACRAL PLATES AND 6.0 AND 7.0 MM BONE SCREWS is an FDA 510(k)-cleared medical device (K081380) 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 November 18, 2008. Regulation: 8.