SpineEX Gains FDA Clearance for Sagittae LLIF

By Julie A. Vetalice

SpineEX received FDA 510(k) clearance to market its Sagittae® expandable device for minimally invasive lateral lumbar interbody fusion (LLIF).

Sagittae is available in five sizes designed for up to 8mm of continuous in situ expansion, with up to 30° of continuous in situ lordotic adjustment. A large single chamber can be filled with bone graft after insertion and adjustment to ensure even contact with both vertebral endplates.

In late 3Q18, SpineEX filed with the U.S. Securities and Exchange Commission to raise up to US $17MM in an initial public offering to support commercialization of spinal fusion devices.

Sources: SpineEX, Inc.; ORTHOWORLD Inc.

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory