
Care Fusion
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AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020 is an FDA 510(k)-cleared medical device (K093463) manufactured by Care Fusion. 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 25, 2010. Regulation: 8.