
Biomet Spine (Aka Ebi, LLC)
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ZYSTON ARC INTERBODY SPACER is an FDA 510(k)-cleared medical device (K110650) manufactured by Biomet Spine (Aka Ebi, 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 June 29, 2011. Regulation: 8.