July 21,2022
3Spine, Inc. Announces IDE Approval
3Spine, Inc., a medical device company developing total joint replacement for the lumbar spine, today announced FDA Investigational Device Exemption (IDE) approval for their US pivotal clinical trial. The company previously completed contracting and site initiation at 16 US centers for a prospective real-world evidence (RWE) fusion study, which has been enrolling since May 2021. As sites complete enrollment of their RWE cohort, each center becomes eligible to participate in the…