Eden Spine’s CE Mark Approval for Thoracolumbar Plate

By Julie A. Vetalice

Eden Spine received CE Mark approval for the SPHYNX™ titanium plating system to treat thoracolumbar instability. The low profile device is implanted via an anterolateral approach, and is indicated for spinal fractures, vertebral tumors, secondary instabilities of the thoracic and thoracolumbar spine and any indication requiring an anterior stabilization low profile.

SPHYNX complements the GIZA™ corpectomy device, an expandable titanium vertebral body replacement with rotatable endplates to provide multiple angulation options. GIZA is intended to replace and fuse vertebral bodies that are collapsed, damaged or unstable due to tumor or fracture.

Eden Spine seeks distribution partners for both devices. GIZA is cleared for marketing in the U.S., EU and Argentina.

Sources: Eden Spine LLC, ORTHOWORLD Inc.

Tags: CE Mark, Regulatory