CDSCO UID IMP/MD/2019/000037_cd18130fc8b46e28546acfef2667baaf_29d2fd01c932e1a95acb1e1ee7472dce
System, Facet Screw Spinal Device
India Medtronic Private Limited·Device Class Class C·India CDSCO·Brand: CD HORIZON SOLERA Spinal System
Registration details
- UID
- IMP/MD/2019/000037_cd18130fc8b46e28546acfef2667baaf_29d2fd01c932e1a95acb1e1ee7472dce
- Device class
- Class C
- Brand name
- CD HORIZON SOLERA Spinal System
- License holder
- India Medtronic Private Limited
- Approving authority
- CDSCO
- Product information
- The UCSS™ SCREW SET is intended to stabilize the spine as an aid to fusion by two different fixation methods. The first fixation method uses the UCSS™ SCREW SET screws as just facet fixation screws, where the screws are inserted bilaterally through the superior side of the facet, across the facet joint at (CD HORIZON SOLERA Spinal System) a single level, and into the pedicle. In the second fixation method, the UCSS™ SCREW SET screws are inserted bilaterally through the superior side of the facet, across the facet joint, and into the pedicle at multiple levels at the same time that a DYNA-LOK® Plate is attached to the base of the spinous processes at the corresponding levels with UCSS™ SCREW SET Screws. The second fixation method should be used when the spine has increased instability or multiple levels need to be fused. Bone graft must be used for both fixation methods. For both methods, this system is indicated for the posterior surgical treatment of any or all of the following at the C2 to S1 (CD HORIZON SOLERA Spinal System) spinal levels: 1) Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis. ; 3) Spondylolysis; 4) Pseudarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; ) Degenerative diseases which include: (CD HORIZON SOLERA Spinal System) Degenerative Disc Disease (CD HORIZON SOLERA Spinal System) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or; (CD HORIZON SOLERA Spinal System) degenerative disease of the facets with instability
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About this record
System, Facet Screw Spinal Device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000037_cd18130fc8b46e28546acfef2667baaf_29d2fd01c932e1a95acb1e1ee7472dce. 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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