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Medical Devices / Submissions and Approvals

SpineEx Earns Additional Clearance for Lumbar Fusion System

March 27, 2019

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.

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