Innovasis Gains FDA Clearance of LxHA Spinal Fusion System

By Julie A. Vetalice

Innovasis received 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®.

Source: Innovasis, Inc.

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory