Nexxt Spine has announced US Food and Drug Administration (FDA) 510(k) clearance of two lumbar based systems, for anterior lumbar interbody fusion (ALIF) and lateral approaches.
The milestone will allow the company to commence in-house manufacturing of the two systems and plan for subsequent alpha launches in August and September respectively, Nexxt Spine said in a press release.
Both systems will showcase the Nexxt Matrixx 3D printed titanium technology unique to the company.
“We are thrilled to be releasing these two powerhouses this year,” said Nexxt Spine president Andy Elsbury. “Our engineering and 3D printing manufacturing teams has been working diligently to simultaneously develop and clear the two products after considerable surgeon demand for Nexxt Spine quality clinical outcomes for ALIF and lateral approaches.”