Aurora Spine Gets FDA Clearance for Spinal Fusion Device

Carlsbad, Calif.-based Aurora Spine has received the FDA’s 510(k) clearance for its Dexasolo-L spinal fusion system.

The 3D printed, color-coded anterior lumbar interbody fusion device is based on the company’s Dexa technology platform, which matches a patient’s bone density and quality to a personalized implant.

Patients’ bone quality has not been previously used to guide manufacturing of spinal implants, so this is “the first of its kind device for lumbar spine in the world,” the company said.

Aurora Spine recently debuted the related Dexa-C cervical implant product line.