www.fdanews.com/articles/196867-fda-clears-standalone-cervical-interbody-fusion-device
FDA Clears Standalone Cervical Interbody Fusion Device
April 29, 2020
The FDA granted 510(k) clearance to Atlas Spine’s standalone version of its expandable cervical interbody system, HiJAK SA.
The adjustable implant features textured titanium-alloy endplates for better osseointegration. The implant’s curvature can be adjusted by up to 20 degrees.
The company said it plans to launch the product this summer.