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ExOss Plus is a Freeze Dried Bone Allograft (FDBA) composed of cortical and cancellous bone. ExOss Plus has optimized porosity of cancellous bone and compactness of cortical bone to provide the best optimal scaffold and structural support for new bone formation.
EXOSS is supplied by Hans Biomed operating in accordance with the Standards for Tissue Banking of the American Association of Tissue Banks (AATB) and Food and Drug Administration (FDA) regulations.
Instructions for Use
- Take out the Vial from the package and place it onto the sterile field using sterile techniques, and then remove the cap.
- Rehydrate contents with sterile saline or the patients own blood in minutes prior to use
- After the contents have been fully rehydrated, loosely fill the bone voids or gaps with the content
Commitment to Quality
The advanced tissue processing and robust quality systems employed by the tissue processor ensure each allograft meets stringent safety and regulatory requirements. Quality standards are established to meet or exceed regulations established by the U.S. Food and Drug Administration (FDA), standards of accredited tissue banks, and other state guidelines as appropriate.
Following processing, allografts are subjected to terminal sterilization or aseptic testing according to the specific allograft specifications. (Note: Mineralized Cortical Cancellous Bone Mix, Small Particle are sterile grafts, and hence are subjected to low-dose, gamma irradiation.)
- Sterile allografts are subjected to low-dose, gamma irradiation validated to Sterility Assurance Level (SAL) of 10 -6.