Empirical Spine had its premarket approval Module II accepted and closed by the FDA for the LimiFlex dynamic sagittal tether.
LimiFlex DST is designed as an alternative to spinal fusion, according to a July 13 news release. It is used for grade 1 degenerative spondylolisthesis patients with spinal stenosis.
The company said it is on track to submit its PMA Module III in 2022. LimiFlex already has the FDA's Breakthrough Device Designation.
"We believe LimiFlex is an exciting advancement in stabilization surgery that uses a completely different concept for durable motion preservation to better meet the pressing need for improved outcomes with a lower cost of care," Richard Treadwell, president and CEO of Empirical Spine, said in the release.