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Orthovita, Inc.
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VITOSS BA BIMODAL BIOACTIVE BONE GRAFT SUBSTITUTE is an FDA 510(k)-cleared medical device (K103173) manufactured by Orthovita, 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 February 6, 2011. Regulation: 8.