
Biomet Spine (Ebi, LLC)
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POLARIS SPINAL SYSTEM is an FDA 510(k)-cleared medical device (K111957) manufactured by Biomet Spine (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 August 18, 2011. Regulation: 8.