SPINAL IMPLANTS - India CDSCO Medical Device Registration

Product Information

Spinal Implants are 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 thoracic, lumbar, and sacral spine: fracture, dislocation, failed previous fusion (INTRAMEDULLARY NAILS), spinal stenosis, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors. Spinal implants are intended to be used as a temporary construct that assists normal healing and are not intended to replace normal body structures. They are intended to stabilize the spinal operative site during fusion procedures and should be removed after fusion. The IMPLANET Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The IMPLANET Spine System is intended for posterior, non-cervical pedicle and nonpedicle fixation for the following indications: degenerative disc disease (INTRAMEDULLARY NAILS), spondylolisthesis, trauma (INTRAMEDULLARY NAILS), spinal stenosis, spinal deformities (INTRAMEDULLARY NAILS), tumor, pseudarthrosis, or revision of a failed fusion attempt