Spinal Elements Receives FDA 510(k) Clearance for Expandable Interbody Device

By Julie A. Vetalice

Spinal Elements received FDA 510(k) clearance to market a line of expandable interbody fusion devices for posterior, anterior and lateral access to the lumbar spine.

The devices will be made primarly from radiolucent PEEK material and will feature Spinal Elements’ Ti-Bond® porous titanium coating at the endplate contact surfaces. Since 2012, Ti-Bond has been successfully used in ~10,000 implants.

Clinical procedures will commence later in 2016, and initial launch is slated for early 2017.

Sources: Spinal Elements, ORTHOWORLD Inc.

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory