SpineEx Earns Additional Clearance for Lumbar Fusion System

SpineEx earned an additional 510(k) clearance for its Sagittae lateral lumbar interbody fusion system after receiving the agency’s initial go-ahead in October 2018.

The 510(k) clearance adds new instrumentation to the system and updates a surgical technique to help streamline implantation by surgeons.

The clearance simplifies the implant sizing process for surgeons and enables them to adjust the implant’s front and rear sides independently.