Spinal Intervertebral Body Fixation Orthosis
- UID
- IMP/MD/2018/000446_b7a3720dee253bbb32ed3aeee49e0aa5_b3d49d462da044db6c3d4df8182d45c3
- Device class
- Class C
- Brand name
- Capstone Spinal System
- License holder
- India Medtronic Private Limited
- Approving authority
- CDSCO
- Product information
- Properly used, this system is intended for anterior interbody screw fixation from C2 to T1. 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 (Capstone Spinal System), 2) trauma (Capstone Spinal System), 3) tumors, 4) deformity (Capstone 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/2018/000446_b7a3720dee253bbb32ed3aeee49e0aa5_b3d49d462da044db6c3d4df8182d45c3. 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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