
Alphatec Spine, Inc.
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NOVEL ALIF SPINAL SPACER SYSTEM is an FDA 510(k)-cleared medical device (K090782) manufactured by Alphatec 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 April 21, 2009. Regulation: 8.