Spinal fixation system - India CDSCO Medical Device Registration

Product Information

LnK Spinal Fixation System/ OpenLoc-L Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (LnK, PathLoc-L), or as an anterolateral fixation system (LnK, PathLoc-L). All components in the system are limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use: • Degenerative disc disease (LnK, PathLoc-L); • Spondylolisthesis; • Trauma (LnK, PathLoc-L); • Deformities or curvatures (LnK, PathLoc-L); • Tumor; • Stenosos and • Failedprevious fusion (LnK, PathLoc-L) The LnK Spinal Fixation System/ OpenLoc-L Spinal Fixation System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (LnK, PathLoc-L) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (LnK, PathLoc-L) with removal of the implants after the attainment of a solid fusion. In addition, the LnK Spinal Fixation System/ OpenLoc-L Spinal Fixation System is 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, spinal tumor and failed previous fusion (LnK, PathLoc-L)