
Biomet Spine (Aka Ebi, LLC)
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POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM is an FDA 510(k)-cleared medical device (K123549) 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 February 24, 2013. Regulation: 8.