Spinal Implants
- UID
- MFG/MD/2023/000585_4fa0dc7bd0f26a0cec29f7e69a03c8a1_cf4c467f260b763446413833fe9bac77
- Device class
- Class C
- Brand name
- Plain and Locking
- License holder
- Komal Health Care Pvt. Ltd.
- Approving authority
- Central Drug Standards Control Organization, West Zone
- Product information
- The Zenium Spinal System, when used for pedicle screw fixation is intended only for patients: a) Having severe spondylolisthesis (Plain and Locking) at the L5-S1 joint; b) Who are receiving fusion using autogenous bone graft only; c) Who are having the device fixed or attached to the lumbar and sacral spine (Plain and Locking); and d) Who are having the device removed after the development of a solid fusion mass. The Zenium Spinal System, when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization thoracic, lumbar, and sacral spine: i. Degenerative spondylolisthesis with objective evidence of neurologic impairment ii. Fracture; iii. Dislocation; iv. Scoliosis; v. Kyphosis; vi. Spinal tumor; and vii. Previous failed fusion (Plain and Locking). The Zenium Spinal System, when used for anterolateral non-pedicle fixation or posterior non-pedicle screw fixation to the non-cervical spine, is intended for the following indications: i. Degenerative disc disease* ii. Spinal stenosis; iii. Spondylolisthesis iv. Spinal deformities (Plain and Locking) v. Pseudoarthrosis vi. Tumor vii. Trauma (Plain and Locking); and viii. Previous failed fusion. *(Plain and Locking)
Spinal Implants is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2023/000585_4fa0dc7bd0f26a0cec29f7e69a03c8a1_cf4c467f260b763446413833fe9bac77. This device is marketed under the brand name Plain and Locking. The license holder is Komal Health Care Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, West Zone.
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