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Innovasis, Inc.
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INNOVASIS EXCELLA SPINAL SYSTEM, EXCELLA-M (MONOAXIAL SCREWS), EXCELLA-P (POLYAXIAL SCREWS) is an FDA 510(k)-cleared medical device (K071921) manufactured by Innovasis, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 15, 2007. Regulation: 8.