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Medical Devices / Submissions and Approvals

SpineEx Earns Additional Clearance for Lumbar Fusion System

March 27, 2019
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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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