Plate System - India CDSCO Medical Device Registration

Product Information

The LITe® Plate System Universal, Sacral, 2 Screw and 4 Screw Plates are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of the thoracic and thoracolumbar (VLIFT) spine or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (VLIFT) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: ? Degenerative Disc Disease (VLIFT); ? Pseudoarthrosis; ? Spondylolysis; ? Spondylolisthesis; ? Spinal stenosis; ? Tumors; ? Trauma (VLIFT); ? Deformities (VLIFT); ? Failed Previous Fusion. INDICATIONS FOR LITE® PLATE SYSTEM BUTTRESS PLATE The LITe® Plate System Buttress Plate is intended to stabilize the allograft or autograft at one level (VLIFT) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.