Back 2 Basics Gains FDA Clearance for eCarbon Spinal Rod

By Julie A. Vetalice

Back 2 Basics Gains FDA Clearance for eCarbon Spinal Rod

Back 2 Basics received FDA 510(k) clearance to market the eCarbon Rod as part of the Dymaxeon Spine System. The device, made of long fiber carbon composite material, is indicated for use in non-cervical spinal fusion.

This is reportedly the first carbon composite spinal rod cleared for market use as an adjunct in the treatment of spinal indications, other than oncological.

eCarbon rods offer radiolucency, allowing the surgeon to more easily visualize bone fusion mass on plain film examination, as well as improved post-op CT and MRI. The rods are available in 5.5mm diameter and in lengths from 35mm to 120mm.

This is the company's second eCarbon market clearance. In 3Q19, both the eCarbon-C anterior cervical cage and the eCarbon-P posterior lumbar cage received FDA 510(k) clearance.

Tags: 510(k) Clearance, Regulatory