Spinal Intervertebral Body Fixation Orthosis
- UID
- IMP/MD/2019/000037_b7a3720dee253bbb32ed3aeee49e0aa5_0bd31d2aa2e54ecc533964ef342cfdb0
- Device class
- Class C
- Brand name
- CD HORIZON SOLERA Spinal System
- License holder
- India Medtronic Private Limited
- Approving authority
- CDSCO
- Product information
- Properly used, this system is intended for anterior interbody screw/plate fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (CD HORIZON SOLERA Spinal System), 2) trauma (CD HORIZON SOLERA Spinal System), 3) tumors, 4) deformity (CD HORIZON SOLERA Spinal System), 5) pseudarthrosis, and/or 6) failed previous fusions
Spinal Intervertebral Body Fixation Orthosis is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000037_b7a3720dee253bbb32ed3aeee49e0aa5_0bd31d2aa2e54ecc533964ef342cfdb0. 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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