CDSCO UID IMP/MD/2019/000037_6743ef5681d69e20b395c9575796a847_a309c192b3f1ef894ffe25d2db97331a
Orthosis, spinal pedicle fixation, for degenerative disc disease
India Medtronic Private Limited·Device Class Class C·India CDSCO·Brand: CD HORIZON SOLERA Spinal System
Registration details
- UID
- IMP/MD/2019/000037_6743ef5681d69e20b395c9575796a847_a309c192b3f1ef894ffe25d2db97331a
- Device class
- Class C
- Brand name
- CD HORIZON SOLERA Spinal System
- License holder
- India Medtronic Private Limited
- 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
Similar products (10)
Other products with the same name or brand
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
Class C
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
Class C
Wire, Surgical(Atlas cable System )
Brand: CD HORIZON SOLERA Spinal System
India Medtronic Private Limited
Class C
Mesh Surgical, Metal
Brand: CD HORIZON SOLERA Spinal System
India Medtronic Private Limited
Class C
System, Facet Screw Spinal Device
Brand: CD HORIZON SOLERA Spinal System
India Medtronic Private Limited
Class C
Spinal Interlaminal Fixation Orthosis
Brand: CD HORIZON SOLERA Spinal System
India Medtronic Private Limited
Class C
Artificial Cervical Disc
Brand: CD HORIZON SOLERA Spinal System
India Medtronic Private Limited
Class C
Spinal Intervertebral Body Fixation Orthosis
Brand: CD HORIZON SOLERA Spinal System
India Medtronic Private Limited
Class C
Spinal Intervertebral Body Fixation Orthosis
Brand: CD HORIZON SOLERA Spinal System
India Medtronic Private Limited
Class C
Orthosis, spinal pedicle fixation, for degenerative disc disease(CD Horizon Spinal System )
Brand: CD HORIZON SOLERA Spinal System
India Medtronic Private Limited
Class C
Other products from India Medtronic Private Limited
Products from the same license holder (10 products)
Portable SpO2 Patient Monitoring System
Brand: Nellcor
Class C
Bedside SpO2 Patient Monitoring System
Brand: Nellcor
Class C
Recharger Kit
Brand: NIL
Class C
Patient Cable
Brand: NIL
Class C
BISX Module
Brand: BIS™
Class C
BISX4 Module
Brand: BIS™
Class C
Complete Monitoring System
Brand: BIS™
Class C
Surgical Cable
Brand: 5832S Cable
Class C
Controller
Brand: HeartWare™ Controller
Class D
Malleable Suction Instrument
Class C
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/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.
This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.