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Precision Spine obtains FDA 510(k) approval for additional components of Reform pedicle screw system

Precision Spine, a spinal device company, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for additional components of its Reform pedicle screw system, designed to treat spinal deformities.

The additional components include a rod to rod connector, pedicle, laminar and transverse process hooks, lateral offset connectors, and parallel cross links and axial domino connectors.

Precision Spine’s Reform system has now been expanded and enhanced with the additional components and these components will allow the system in achieving alignment and correction at each level of the thoracic, lumbar and sacral spine.

Polyaxial and uniplanar pedicle screw designs are offered by the Reform system and these two designs have a triple lead thread, cobalt chrome tulip head, titanium and cobalt chrome rods, and titanium cross connectors.

The ergonomic instrument set features versatile reduction direct vertebral de-rotation tower system.

The Reform pedicle screw system immobilizes and stabilizes spinal segments in skeletally mature patients with degenerative spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion.

It is also intended for non-cervical pedicle screw fixation, trauma, spinal stenosis; curvatures, spinal tumor, pseudarthrosis, and failed previous fusion.