Longitudinal stabilization of the thoracic and lumbar spine
Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·MEDICREA INTERNATIONAL S.A.·Registered Oct 02, 2024- Analysis ID
- 2402746ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-220421-0023
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- MEDICREA INTERNATIONAL S.A.
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- MEDICREA INTERNATIONAL S.A.
- Authorized Representative
- CÔNG TY TNHH MEDTRONIC VIỆT NAM
- Intended Use
- The thoracolumbar lateral spinal rods used individually for each patient MEDICREA™ INTERNATIONAL S.A. UNiD™ are medical devices designed to contribute to the correction and stabilization of surgery limited to the thoracic, lumbar and sacral spine. These devices are NOT TO BE used in the cervical region. They must be used in conjunction with the associated spinal fixation devices. These implantable devices are designed to stabilize the spine during the process of achieving the normal, strong bone fusion. After this period, the presence of the device is no longer required and can be removed. Indications: The thoracolumbar lateral spinal rods used individually for each patient MEDICREA™ INTERNATIONAL SA UNiD™ are used in conjunction with different spinal anchoring elements of the associated spinal fixation system, in order to provide the stabilization and fixation of the spinal segments in the adult bone, as a support measure for the fusion in the treatment 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 deformities or curvatures of the spine, such as scoliosis, kyphosis and/or lordosis, or congenital scoliosis in adolescence. 6. Instability due to tumor. 7. Failed prior fusion (prosthetic joint)
- Registration Date
- Oct 02, 2024
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Access comprehensive regulatory information for Longitudinal stabilization of the thoracic and lumbar spine in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2402746ĐKLH/BYT-HTTB and manufactured by MEDICREA INTERNATIONAL S.A.. The authorized representative in Vietnam is CÔNG TY TNHH MEDTRONIC VIỆT NAM.
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