
Spineworks, LLC
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A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.) is an FDA 510(k)-cleared medical device (K111166) manufactured by Spineworks, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 7, 2011. Regulation: 8.