Atlas Spine Gains FDA Clearance for Expandable Stand-Alone Cervical Interbody

By Julie A. Vetalice

Atlas Spine Gains FDA Clearance for Expandable Stand-Alone Cervical Interbody

Atlas Spine received FDA 510(k) clearance to market the HiJAK SA Expandable Stand-Alone (SA) Cervical Interbody System.

HiJAK SA joins the company's HiJAK AC and the V3 segmental plating in the company's disruptive design portfolio. Both HiJAK systems allow intra-operative customization of height and lordosis. HiJAK SA incorporates an integrated low-profile plate that improves screw access during minimally invasive applications and screw-to-bone integrity, as an alternative to current stand-alone devices.

“It was our goal from the onset to develop the most comprehensive and innovative offerings for treating complex cervical pathologies,” said Matt Baynham, CEO and co-founder of Atlas Spine. “With the addition of the standalone variant to our expandable cervical interbody and guided segmental plating system, we can now address broader patient conditions and surgical preferences."

Product Labels: Cervical Spine, Spinal Fusion

Tags: 510(k) Clearance, Regulatory