Astura Medical Receives FDA 510(k) Clearance For Dolomite Stand-Alone Anterior Cervical Stabilization System

Astura Medical was granted FDA 510(k) clearance to market the Dolomite Stand-Alone Anterior Cervical Stabilization System.

Dolomite is the company’s third technology providing a combined interbody and fixation option to receive 510k approval within the last 6 months.

Dolomite offers either HA PEEK or acid-etched titanium interbody spacers in a range of heights, widths and lordotic options. Intraoperatively, surgeons can choose 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 repeatable approach that can accommodate varying anatomical challenges.

“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.”