Parsippany, N.J.-based Precision Spine obtained FDA 510(k) clearance for its AccuFit lateral plate system, according to Mass Device.
Here are four notes:
1. Precision Spine devised the AccuFit lateral plating system to treat spinal instability.
2. Non-sterile, single use rigid plates compose the device, allowing plates to attach to the thoracolumbar spine's vertebral body's lateral portions via bone screws.
3. Surgeons can use the device through a lateral or anterolateral surgical approach. They can use the device above the great vessels' bifurcation to treat thoracic and thoracolumbar spine instability or via an anterior surgical approach below the great vessels' bifurcation to treat lumbar and lumbarsacral spine instability.
4. In September 2016, Precision Spine earned FDA 510(k) clearance for its reform modular and hydroxyapatite coated pedicle screw systems.