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*Summary of Indications for Use

The EXOGEN Ultrasound Bone Healing System is indicated for the non-invasive treatment of established nonunions† excluding skull and vertebra. In addition, EXOGEN is indicated for accelerating the time to a healed fracture for fresh, closed, posteriorly displaced distal radius fractures and fresh, closed or Grade I open tibial diaphysis fractures in skeletally mature individuals when these fractures are orthopedically managed by closed reduction and cast immobilization.

There are no known contraindications for the EXOGEN device. Safety and effectiveness have not been established for individuals lacking skeletal maturity, pregnant or nursing women, patients with cardiac pacemakers, on fractures due to bone cancer, or on patients with poor blood circulation or clotting problems. Some patients may be sensitive to the ultrasound gel. Full prescribing information can be found in product labelling, at EXOGEN.com, or by calling customer service at 1-800-836-4080.

†A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.

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