Spinal Implants
- UID
- MFG/MD/2021/000090_4fa0dc7bd0f26a0cec29f7e69a03c8a1_7af15317e041f0e46da2cd815853a45d
- Device class
- Class C
- Brand name
- FineOrtho
- License holder
- Fine Ortho
- Approving authority
- Central Drug Standards Control Organization, Ahmedabad
- Product information
- Pedical Screw System: The Spine Pedicle Screw System is a thoracolumbosacral (FineOrtho) spinal fixation system containing devices intended for use as a posterior pedicle screw fixation system. Pedicle screw fixation is limited to skeletally mature patients. These devices are intended as an adjunct to fusion for all the following indications: degenerative disc disease (FineOrtho), spondylolisthesis, trauma (FineOrtho), spinal stenosis, curvatures (FineOrtho), tumour, and/or failed previous fusion (FineOrtho). Interbody Fusion Cages: Interbody fusion cageshelps in maintaining space between the vertebras, in preserving spinal alignment and promotes spinal fusion. Vertebral Body Replacement System: It is used to replace collapsed, damaged or unstable vertebral bodies due to any sort of trauma or tumor. The Cervical Plate system: It is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (FineOrtho). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with degenerative disc disease (FineOrtho), spondylolisthesis, trauma (FineOrtho), tumors, deformity (FineOrtho), pseudoarthrosis, failed previous fusion, and/or spinal stenosis
Spinal Implants is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2021/000090_4fa0dc7bd0f26a0cec29f7e69a03c8a1_7af15317e041f0e46da2cd815853a45d. This device is marketed under the brand name FineOrtho. The license holder is Fine Ortho, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.
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