Orthosis, spinal pedicle fixation, for degenerative disc disease - India CDSCO Medical Device Registration
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/2019/000037_6743ef5681d69e20b395c9575796a847_a309c192b3f1ef894ffe25d2db97331a. This device is marketed under the brand name CD HORIZON SOLERA 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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Brand Name
CD HORIZON SOLERA Spinal System
License Holder
India Medtronic Private LimitedDevice Class
Approving Authority
CDSCO
Product Information
The GDLH Posterior Spinal System, when using TSRH Variable Angle Screws or DYNA-LOK bolts as pedicle screws, is intended only for patients (CD HORIZON SOLERA Spinal System) having severe spondylolisthesis (CD HORIZON SOLERA Spinal System) of the fifth lumbar first sacral (CD HORIZON SOLERA Spinal System) vertebral joint; (CD HORIZON SOLERA Spinal System) who are receiving fusions using autogenous bone graft only; (CD HORIZON SOLERA Spinal System) who are having the device fixed or attached to the lumbar and sacral spine: and (CD HORIZON SOLERA Spinal System) who are having the device removed after the development of a solid fusion mass. Properly used, this system is intended to assist stabilization until a solid spinal fusion develops. Except for situations where screws are attached to the pedicles of the lumbar and sacral spine via a posterior surgical approach in a GDLH construct for the treatment of severe spondylolisthesis (CD HORIZON SOLERA Spinal System) at the L5-S1 vertebral joint, the specific indications for the GDLH Posterior Spinal System are the following: 1. Degenerative disc disease (CD HORIZON SOLERA Spinal System). 2. Pseudoarthrosis. 3. Stenosis. 4. Spondylolisthesis. 5. Spinal deformities such as scoliosis, kyphosis, and lordosis. 6. Fracture. 7. Unsuccessful previous attempts at spinal fusion. 8. Tumor resection
Orthosis, spinal pedicle fixation, for degenerative disc disease
Brand: CD HORIZON® Spinal System
India Medtronic Private Limited ,Shed No. 3, Block No. 1, Survey No. 389, 400/2A & 2C, Pudur Main Road, Kuthambakkam - 600124, Poonamallee Taluk, Tiruvallur District ,Tiruvallur Tamil Nadu ,600124 ,India
Orthosis, spinal pedicle fixation, for degenerative disc disease
Brand: CD HORIZON® Spinal System
India Medtronic Private Limited ,Shed No. 3, Block No. 1, Survey No. 389, 400/2A & 2C, Pudur Main Road, Kuthambakkam - 600124, Poonamallee Taluk, Tiruvallur District ,Tiruvallur Tamil Nadu ,600124 ,India
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