Spinal Implants - India CDSCO Medical Device Registration

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)