RegulatorySpine

Astura Medical Receives FDA 510(k) Clearance For HALF DOME X Expandable Posterior Lumbar Interbody System

CARLSBAD, CA – May 3, 2019 – 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 Half Dome X Expandable Posterior Lumbar Interbody System.

The Half Dome X system delivers a new level of intraoperative flexibility and efficiency by providing infinitely adjustable expansion of height and width of the interbody spacer for a controlled restoration of disc height and optimized fit. These features, coupled with acid-etched endplates of the implant and an integrated bone graft delivery system within the inserter, maximize bone graft volume and endplate contact. The wide array of implant options and expansive instrumentation delivers a streamlined, efficient procedural sequence that can address even the most difficult pathologies through multiple approaches.

“I’m thrilled by the effort of our engineers and surgeon design team partners, as we were able to solve the existing challenges in the expandable posterior interbody marketplace to create what we believe to be a best-in-class system,” said Thomas Purcell, Co-founder and Vice President.

Half Dome X is now commercially available in multiple footprint, height, and lordotic options for PLIF, OTLIF, and TLIF procedures. In addition to the launch of their first expandable spacer, Astura will be introducing its Cervical Corpectomy Cages and additional Deformity Solutions in the coming months.

For more information on Half Dome X, click here.

About Astura Medical

Astura Medical was formed in 2014 with the objective of creating a disciplined, multi-phased approach to developing, manufacturing, and distributing medical devices. With surgeon input and feedback at every stage of development, Astura has created an extensive line of devices of the highest quality and sleekest design.

The two essential pillars that contribute to Astura Medical’s success are high quality products and robust distribution channels. These pillars, combined with passion and innovation, are what drive the Astura team to achieve great success with developing devices and entering them into the marketplace.

For more information, please visit www.asturamedical.com or find us on LinkedIn.

Media Contact:

Steve Haayen

Astura Medical

858.472.8825

steve@asturamedical.com

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Mason Krell

Mason began his career in the Orthopedic Industry in 2017 when he joined The De Angelis Group as a Research Manager. He has developed a strong network within the industry and is very dedicated to helping companies maximize opportunities and disrupt markets.

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