Spine Implant - India CDSCO Medical Device Registration

Product Information

The Xia 3 Spinal System is intended for use in the noncervical spine. When used as an anterior anterolateral and posterior non cervical pedicle and nonpedicle fixation system, the Xia® 3 Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: • Degenerative Disc Disease (AVS Anchor-L Cage System) • Spondylolisthesis • Trauma (AVS Anchor-L Cage System) • Spinal stenosis • Curvatures (AVS Anchor-L Cage System) • Tumor • Pseudarthrosis • Failed previous fusion The 5.5 mm rods from the Stryker Spine Radius™ Spinal System and 6.0 mm Vitallium rods from the Xia® Spinal System are intended to be used with the other components of the Xia® 3 Spinal System. When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Xia® 3 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (AVS Anchor-L Cage System) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Xia® 3 Spinal System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach