Longitudinal stabilization of the thoracic and lumbar spine
Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·MEDICREA INTERNATIONAL S.A.·Registered Nov 02, 2024- Analysis ID
- 2403071ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-220421-0020
- 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 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)
- Registration Date
- Nov 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 2403071ĐKLH/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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