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www.fdanews.com/articles/196737-astura-gets-510k-clearance-for-lumbar-interbody-fusion-system

Astura Gets 510(k) Clearance for Lumbar Interbody Fusion System

April 21, 2020

Astura Medical received 510(k) clearance from the FDA for its Sirion lateral lumber interbody fusion system for lateral spinal surgery.

The device can be customized to meet a patient’s needs, including spacers in numerous lengths, widths, heights and curvature options.

The Sirion system is the company’s first product that combines interbody and fixation options in a single device for lateral lumbar surgery.

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