Vít đa trục rỗng nòng bơm xi măng
Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Medtronic Plc·Registered Nov 02, 2024- Analysis ID
- 2403098ĐKLH/BYT-HTTB
- Submission ID
- 17001733/ĐKLH-BYT-TB-CT
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Medtronic Plc
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Medtronic Plc
- Authorized Representative
- CÔNG TY TNHH MEDTRONIC VIỆT NAM
- Intended Use
- Purpose: The CD HORIZON™ SOLERA™ Intramedullary Cement-Fillable Multiaxial Screw is an adjunct to the CD HORIZON™ Spinal Fixation System and is intended to be used as a support component for the healing process of the thoracic, lumbar, or sacral vertebrae. Indications: The CD HORIZON™ SOLERA™ Intramedullary Cement-Fillable Multiaxial Screw is indicated for use in the fixation of the spine, excluding the cervical spine, from the posterior approach to support the healing process for the following conditions: degenerative disc disease (DDD - when determined to be the cause of low back pain based on the patient's history and confirmed by the radiographic findings), degenerative spondylolisthesis, fracture (i.e., a broken bone or dislocation), spinal stenosis, scoliosis, kyphosis, or lordosis, tumor, arthroplasty, and/or failure of a prior bone grafting procedure. When used in combination with the Cement-Fillable Multiaxial Screw, the CD HORIZON™ SOLERA™ Intramedullary Cement-Fillable Multiaxial Screw is indicated to enhance the fixation of the spinal cord in patients with compromised/bone deficient vertebrae.
- Registration Date
- Nov 02, 2024
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Access comprehensive regulatory information for Vít đa trục rỗng nòng bơm xi măng 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 2403098ĐKLH/BYT-HTTB and manufactured by Medtronic Plc. The authorized representative in Vietnam is CÔNG TY TNHH MEDTRONIC VIỆT NAM.
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