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Reimbursement / Regulatory

Aegis Spine Gains FDA Clearance for AccelFix Expandable Cage -

Aegis Spine received FDA 510(k) clearance to market the AccelFix Expandable Cage System. Product launch is underway. The system 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.  (Aegis Spine, 10/9/19)