Spinal System - Monarch - Connector -Non-Sterile - Titanium - India CDSCO Medical Device Registration

Product Information

The ISOLA, VSP, MOSS MIAMI, TIMX and MONARCH Spine Systems are pedicle screw systems intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis,spinaltumor, and failed previous fusion (Non-Sterile).The ISOLA, VSP, MOSS MIAMI, TIMX and MONARCH Spine Systems are also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Non-Sterile) of the L5–S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (Non-Sterile) with removal of the implants after the attainment of a solid fusion.The ISOLA, MOSS MIAMI, TIMX and MONARCH Spine Systems are also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (Non-Sterile), spondylolisthesis, trauma (Non-Sterile), spinal stenosis, deformities (Non-Sterile),tumor, and previous failed fusion (Non-Sterile).The ISOLA, VSP, and MONARCH Spine Systems when used with pedicle screws are indicated for degenerative disc disease (Non-Sterile). Levels of fixation are for the thoracic, lumbar and sacral spine. The MONARCH Spine System Dual Rod Connectors can be used to connect MONARCH Spine System Rods to rods of other DePuy Spine 4.75mm, 5.5mm, and 6.35mm diameter rod systems