Is TruFUSE® FDA approved?
TruFUSE® is made of allograft (donated cortical bone derived from both the femur and tibia). Donated human tissue production and processing is regulated by the FDA under 21 CFR Part 1271 – HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS. TruFUSE® Allograft is processed by licensed tissue banks which are fully compliant with all FDA requirements for tissue processing in the United States.
