Astura Medical Receives FDA 510(k) Clearance For Dolomite Stand-Alone Anterior Cervical Stabilization System
Astura Medical, a high-growth, innovative spine technology company, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Dolomite Stand-Alone Anterior Cervical Stabilization System.
Expanding on the rapid adoption and recent success of the company’s other integrated plate and spacer technologies for anterior lumbar and lateral lumbar procedures, Dolomite was designed to deliver the widest array of construct options with the most efficient and streamlined supporting instrumentation in the anterior cervical surgery marketplace today.
“Even in market segments that are well established and relatively commoditized, we are continuing to find ways to improve from other currently available technology,” said Joel Gambrell, Co-founder and CEO. “Dolomite is yet another example of our R&D Team, alongside our surgeon design partners, reestablishing the benchmark of what is considered to be the best-in-class solution for a specific procedure.”
Dolomite provides the choice of either HA PEEK or Acid-etched Titanium interbody spacers in an extensive range of heights, widths, and lordotic options. The system provides the intraoperative flexibility to select between either a zero-profile, half plate, or full plate that can be implanted in conjunction with the interbody. By providing either anchoring nails or screws, which can be delivered via multiple techniques including an “All-in-One” option, Dolomite provides a streamlined, repeatable set of solutions that can accommodate the varying anatomical challenges presented in anterior cervical surgery.
Dolomite is the company’s third technology platform providing a combined interbody and fixation option to receive 510k approval within the last 6 months.