Eden Spine Gains FDA Clearance for SPHYNX Thoracolumbar Plate

By Julie A. Vetalice

Eden Spine gained FDA 510(k) clearance to market the SPHYNX™ titanium plate to treat thoracolumbar instabilities. SPHYNX complements GIZA™, an expandable titanium vertebral body replacement with rotatable endplates.

SPHYNX is implanted in an anterolateral approach. The device was granted CE Mark approval in 2016.

Sources: Eden Spine Europe SA; ORTHOWORLD Inc.

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory