
K2m, Inc.
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ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01 is an FDA 510(k)-cleared medical device (K080024) 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 January 23, 2008. Regulation: 8.