Home » Maker of Spine Replacement Systems Warned for Procedural Shortcomings
Maker of Spine Replacement Systems Warned for Procedural Shortcomings
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. Lucero makes a product called Enduramesh, an implantable spinal vertebral replacement device available in multiple lengths and diameters and which come with complimentary mesh trimmers.
The GMP Letter
The GMP Letter
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