Aegis Spine Gains FDA Clearance for AccelFix Expandable Cage

By Julie A. Vetalice

Aegis Spine, subsidiary of L&K BioMed, was granted FDA 510(k) clearance for AccelFix Expandable Cages. The devices launched in the U.S. earlier this month.

The system, pictured below, comprises sterile-packaged titanium alloy-based TLIF/PLIF cages (AccelFix-XT), an expandable lateral interbody (AccelFix-XL), and an Anterior-to-Psoas expandable interbody specifically contoured to avoid the contralateral nerve root (Accelfix-XTP).

AccelFix devices are complemented by a 5.5 rod spinal fixation system which earned FDA 510(k) clearance earlier this year.

 

 

 

Source: Aegis Spine, Inc.

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory