Spinal fusion device draws FDA warning letter
Spinal device company Lucero Medical has received a warning letter from the U.S. Food and Drug Administration, primarily over documentation and quality-control issues. Hinckley, Ohio-based Lucero produces a cylindrical-shaped, titanium mesh device that’s implanted in the spine to replace collapsed or diseased vertebrae. The device, called the Enduramesh, is designed to aid in spinal fusion. […]