Allograft / DirectGen™ - DirectGen is an allograft ideally suited for optimal results in a variety of surgical applications. The donor screening has robust quality systems built into every stage of allograft production starting with screening and eligibility determination.  Quality standards are established to meet or exceed the regulations and guidelines of the FDA, the AATB, and individual state health departments. Sterile allografts are subjected to low-dose, gamma irradiation validated to Sterility Assurance Level (SAL) of 10-6.