The FDA has granted Innovasis 510(k) clearance for its LxHA lateral interbody fusion device for use with internal supplemental spinal fixation systems.
The device has a bullet-shaped nose to improve insertion and osteoconductive properties to promote bone growth. The interior is intended to be packed with autograft.
The LxHA is intended to be used with internal supplemental spinal fixation systems such as the Excella spinal system.
The company said it expects to launch the product in the United States in the third quarter of 2019.