AO Custom RX Form

Based on medical expertise as a practicing physician I have determined that the devices generally available through commercial distribution are not suitable to treat the patient named below. The custom device described below is intended to provide the most effective treatment for the patient by meeting their unique needs. The custom device is intended to be used solely by me to treat the patient. This custom implant falls under the guidance of custom device exception contained in Section 520(b). I recognize promotion of custom devices is in violation of the regulation and anything I post online about the custom device is not approved nor endorsed by Paragon 28. As a practicing physician, I have requested this custom device which is not generally available to or used by other physicians and is intended to be used solely by me to treat my patients. As a physician I have determine that this is the only suitable option left for my patient.