Lumber Spacer
- UID
- IMP/MD/2019/000005_d58404d6a47c25f5b4bb1b0e441123ca_76ee0745f44f1b5786d9679ebf359022
- Device class
- Class B
- Brand name
- TRANSITION Stabilization System
- License holder
- M/s Globus Medical India Pvt. Ltd.
- Approving authority
- CDSCO
- Product information
- Intended for the cervical spine (TRANSITION Stabilization System), for anterior cervical discectomy and fusion (TRANSITION Stabilization System) in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These devices are recommended to be used with supplemental spinal fixation systems for cervical spine (TRANSITION Stabilization System)
Lumber Spacer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000005_d58404d6a47c25f5b4bb1b0e441123ca_76ee0745f44f1b5786d9679ebf359022. This device is marketed under the brand name TRANSITION Stabilization System. The license holder is M/s Globus Medical India Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is CDSCO.
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