BONE PLATE - India CDSCO Medical Device Registration

Product Information

Bone Plates intended to be attached to fractured long bone fragment with screw to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals. it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis.,: SPINAL IMPLANTS(ORTHOFLEX MEDISYS INDIA PVT. LTD.)-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 (ORTHOFLEX MEDISYS INDIA PVT. LTD.), 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 (ORTHOFLEX MEDISYS INDIA PVT. LTD.), spondylolisthesis, trauma (ORTHOFLEX MEDISYS INDIA PVT. LTD.), spinal stenosis, spinal deformities (ORTHOFLEX MEDISYS INDIA PVT. LTD.), tumor, pseudarthrosis, or revision of a failed fusion attempt