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Osteosymbionics, LLC
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OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT is an FDA 510(k)-cleared medical device (K111069) manufactured by Osteosymbionics, LLC. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 21, 2011. Regulation: 8.