CDSCO UID IMP/MD/2019/000037_8396a03a5e9b6de92303612e03748d93_e68212b58a07c0add776caa7ee96fe8d
Intervertebral Body Fusion Device
India Medtronic Private Limited·Device Class Class C·India CDSCO·Brand: CD HORIZON SOLERA Spinal System
Registration details
- UID
- IMP/MD/2019/000037_8396a03a5e9b6de92303612e03748d93_e68212b58a07c0add776caa7ee96fe8d
- Device class
- Class C
- Brand name
- CD HORIZON SOLERA Spinal System
- License holder
- India Medtronic Private Limited
- Approving authority
- CDSCO
- Product information
- The CRESCENT® Spinal System Titanium is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (CD HORIZON SOLERA Spinal System) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants are to be used with autogenous bone graft. These devices are intended to be used with Medtronic supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine
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About this record
Intervertebral Body Fusion Device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000037_8396a03a5e9b6de92303612e03748d93_e68212b58a07c0add776caa7ee96fe8d. 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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