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Life Spine, Inc.
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PRO-LINK CERVICAL SPACER SYSTEM is an FDA 510(k)-cleared medical device (K121151) manufactured by Life Spine, 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 15, 2012. Regulation: 8.