RegulatorySpine

Astura Medical Receives FDA 510(k) Clearance For ALTA Anterior Cervical Corpectomy Spacer System

IRVING, TX – November 13, 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 Alta Anterior Cervical Corpectomy Spacer System.

“Our aim was to design a simple and efficient system that would allow our surgeon partners the intraoperative flexibility necessary to accommodate the wide array of anatomical challenges consistently encountered when performing a cervical corpectomy,” said Thomas Purcell, Vice President and Cofounder of Astura Medical. “We believe the Alta Cervical Corpectomy System has delivered on that goal, along with further complementing our other best-in-class cervical solutions, Bridalveil OCT and Zion.”

Available in either HA PEEK or Acid-etched Ti surface options, the system provides four different axial footprints in heights ranging from 15 – 50mm in 1mm increments. These features, coupled with a large central aperture for packing bone graft, maximize the contact between the implant and the vertebral body to help provide a greater opportunity for fusion.

In addition to the full commercial release of Alta Corpectomy, Astura will be launching its integrated plate/spacer platforms for Lateral Lumbar Interbody Fusion (LLIF), Anterior Lumbar Interbody Fusion (ALIF), and Anterior Cervical Discectomy and Fusion (ACDF) in the early part of next year.

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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Josh Sandberg

Josh Sandberg is the President of Ortho Spine Partners and Partner for The De Angelis Group. He also serves as Co-Founder and Editor of OrthoSpineNews.

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