Longitudinal stabilization of the thoracic and lumbar spine - Vietnam Registration 2403071ĐKLH/BYT-HTTB

The MEDICREA™ INTERNATIONAL S.A.UNiD™ Spinal Fixation Systems are medical devices designed to contribute to the correction and stabilization of the spine, specifically for the correction and stabilization of the thoracic, lumbar and sacral spine. The Spinal Fixation Systems must be used in conjunction with the different PASS LP™ or PASS TULIP ™ components. These devices are NOT indicated for the cervical spine. These implantable devices are designed to stabilize the spine during the process of achieving a strong, solid union, which typically takes about 12 months. After this period, the presence of the device is no longer required and can be removed. Indications: The MEDICREA™ INTERNATIONAL S.A.UNiD™ Spinal Fixation Systems are used in conjunction with different spinal fixation components of the PASS LP™ or PASS TULIP™ systems, to provide stabilization and correction of the spine in adult patients with bone, as a support measure for the healing of acute and chronic instability or deformity of the thoracic, lumbar and sacral spine. 1. Degenerative disc disease. 2. Trauma (bone fracture, dislocation). 3. Spinal stenosis. 4. Spondylolisthesis. 5. Various types of spinal deformities or spinal curvatures, such as scoliosis, kyphosis and / or lordosis, or congenital scoliosis in adolescents. 6. Instability due to a tumor. 7. Failed previous fusion (prosthetic joint)