Precision Spine has received 510(k) clearance from the FDA for its Mini-Max Minimally Invasive Access System.
The addition of the Mini-Max Minimally Invasive Access System to the company’s expanding array of minimally invasive spinal solutions will enable spine surgeons to perform minimally invasive procedures using a versatile “access/fixation” system that has been designed to achieve results using a minimally disruptive procedure, that are the same as or better than those achieved using the “gold standard”, open procedures.
The Mini-Max System is intended for use with the company’s S-LOK Pedicle Screw System. The S-LOK 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 neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The S-LOK System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4 of the L5-S1 vertebra) in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudarthrosis, and failed previous fusion.
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