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Medical Devices / Submissions and Approvals

FDA Clears Cutting Edge Spine’s Cervical Spine Interbody Implant

July 13, 2018

Cutting Edge Spine announced that the FDA granted 510(k) clearance for its EVOL ha-C cervical interbody system.

The company also plans to release anterior lumbar interbody fusion, oblique lateral interbody fusion and direct lateral interbody fusion systems later in the year.

The system is made of PEEK-OPTIMA HA enhanced material that is used in the creation of implants. Implants made from the material have shown to cause early onset bone formation and bony apposition to the implant during fusion.

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