
Ebi, L.P.
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EBI OMEGA21 SPINAL FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K031354) manufactured by Ebi, L.P.. 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 5, 2003. Regulation: 8.