CarboFix's CarboClear Carbon Fiber Pedicle Screw System received 510(k) FDA clearance.
Here are three things to know about the device:
1. The CarboClear system restores the integrity of the spinal column in the absence of fusion.
2. The device works for a limited time in patients with advanced stage thoracic and lumbar spine tumors whose life expectancy doesn’t permit fusion.
3. The CarboClear system allows the use of radiation therapy without harming surrounding tissue and lets radiation pass through without reduction of the dose level.