Astura Medical receives FDA clearance for Dolomite Stand-Alone Anterior System


Astura Medical, Texas, USA, has received 510(K) clearance from the US Food and Drug Administration (FDA) for its Dolomite Stand-Alone Anterior Cervical Stabilization System.

The Dolomite system allows for the choice between HA PEEK or Acid-etched Titanium interbody spacers in a range of heights, widths, and lordotic options. It also provides intraoperative flexibility to select between either a zero-profile, half plate, or full plate that can be implanted in conjunction with the interbody.

The Dolomite system is designed for a wide array of construct option, for the efficient instrumentation in the anterior cervical surgery marketplace.


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