CDSCO UID IMP/MD/2018/000446_f51e88b40c6c3bf7582217ee2cba6b18_078641df2d4e1ee03f10082b2ed49198
Orthosis, spinal pedicle fixation for degenerative disc disease
India Medtronic Private Limited·Device Class Class C·India CDSCO·Brand: Capstone Spinal System
Registration details
- UID
- IMP/MD/2018/000446_f51e88b40c6c3bf7582217ee2cba6b18_078641df2d4e1ee03f10082b2ed49198
- Device class
- Class C
- Brand name
- Capstone Spinal System
- License holder
- India Medtronic Private Limited
- Approving authority
- CDSCO
- Product information
- The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (Capstone Spinal System), spondylolisthesis, trauma (Capstone Spinal System), spinal stenosis, curvatures (Capstone Spinal System), tumor, pseudarthrosis, and/or failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion. With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON® Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities(Capstone Spinal System) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis and fracture caused by tumor and/or trauma. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. The CD HORIZON® SPIRE™ Plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (Capstone Spinal System) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: degenerative disc disease (Capstone Spinal System), spondylolisthesis, trauma, and/or tumor. In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use
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About this record
Orthosis, spinal pedicle fixation for degenerative disc disease is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000446_f51e88b40c6c3bf7582217ee2cba6b18_078641df2d4e1ee03f10082b2ed49198. This device is marketed under the brand name Capstone Spinal System. The license holder is India Medtronic Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.
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