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Reimbursement / Regulatory

Innovasis Gains FDA Clearance of LxHA Spinal Fusion System -

Innovasis was granted FDA 510(k) clearance to market the PEEK-OPTIMA® HA Enhanced LxHA™ device for lateral interbody fusion. Full launch is slated for 3Q19. LxHA will complement a new next generation retractor system launched to be launched by the end of the year. The interbody device features a bullet-shaped nose, large central graft window and pyramid-shaped teeth to help resist migration. It is intended for use with internal supplemental spinal fixation, such as Innovasis Excella®. (Innovasis, 6/25/19)