FDA guidance recommends that implantable devices have a sterility assurance level of 10-6.

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Consistent graft thickness to help support a uniform repair.

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The same potential medical/surgical conditions or complications that apply to any surgical procedure may occur during or following implantation. The surgeon is responsible for informing the patient of the risks associated with their treatment and the possibility of complications or adverse reactions. As with any human tissue implant, it is not possible to guarantee freedom from transmission of infectious agents or other adverse reactions such as hypersensitivity, allergic or immune response.