DevicePMAs@therightstef:P910066_S012 JSONTXT 11 Projects

Modifications to the sizes of the device. The device, as modified, will be marketed under the trade name Orthologic 1000-SC and is indicated for the noninvasive treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.