BACK 2 BASICS GRANTED 510(K) CLEARANCE FOR eCARBON SPINAL ROD

eCarbon Rod


INDEPENDENCE, OHIO—May 12, 2020.  The FDA notified Back 2 Basics today that the eCarbon Rod as part of the Dymaxeon Spine System has been cleared for market.  The eCarbon rod, made of long fiber carbon composite, is for use in non-cervical spinal fusion procedures for indications including:  DDD, stenosis, spondylolisthesis, spinal deformities, tumor, trauma and failed fusions.

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

During mechanical testing eCarbon rods performed structurally comparable to equivalent metallic components.  Significant advantages include radiolucency allowing the surgeon to more easily visualize bone fusion mass on plain film examination as well as improved CT and MRI postoperatively.

eCarbon rods are available in 5.5mm diameter and in lengths from 35mm to 120mm. 

This is the second eCarbon market clearance for Back 2 Basics – last September both the eCarbon-C anterior cervical cage and the eCarbon-P posterior lumbar cage were cleared.


For more information contact:
Back 2 Basics LLC.
6701 Rockside Road
Suite 200
Independence, OH  44131
216 447 5025
info@back2basicsdirect.com

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