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FDA Clears Astura Medical’s Cervical Stabilization System

November 11, 2020

The FDA has granted Astura Medical 510(k) clearance for Dolomite, a system used for rigid anterior cervical stabilization.

The system includes either a polymer enhanced with hydroxyapatite, the main inorganic component of bone, or acid-etched titanium interbody spacers in an array of heights, widths and curved options.

The device uses either anchoring nails or screws that can be delivered via multiple techniques, helping surgeons to address the anatomical challenges encountered in anterior cervical surgery.

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