Renovis Surgical Receives FDA Clearance of Tesera SC Cervical Interbody Fusion System

By Julie A. Vetalice

Renovis Surgical received FDA 510(k) clearance to market the Tesera™ SC porous titanium cervical interbody fusion system.

The standalone system, like all Tesera implants, is fabricated via additive manufacturing (3D printing) to create a highly-porous surface structure.

Source: Renovis Surgical Technologies, Inc.

This is the fourth product group featuring Tesera porous titanium for which Renovis has received FDA clearance, following:

  • Tesera SA for standalone anterior spinal fusion (cleared 3Q13)
  • Tesera Acetabular for adult reconstruction (cleared 2Q14)
  • Tesera Posterior Lumbar Interbody (cleared 1Q15)

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory