510(k) Violations, Manufacturing Woes Land Spine Company a Warning Letter

Lucero Medical, an Ohio-based maker of vertebral body replacement devices, has been warned for lacking a slew of basic manufacturing procedures and for various 510(k) clearance violations. The company makes a product called Enduramesh, an implantable spinal vertebral replacement device available in multiple lengths and diameters and with complimentary mesh trimmers.
Device & Diagnostics Letter