Axis Spine Technologies, Ltd. was granted FDA 510(k) clearance on May 20, 2020 for its first device, a modular interbody fusion device for anterior lumbar interbody fusion (ALIF), the Axis-ALIF. The device was cleared just over three months after submission for single and contiguous 2-level use.
The company plans to have the device available for surgery by August or September of this year. Axis Spine, based in St. Albans, UK near London, decided to forego CE marking preferring to first enter the U.S. market. There, the company hopes to generate clinical data to support future clearances.