Spinal Elements Receives Additional FDA 510(k) Clearance for Ti-Bond Coating Technology

By Julie A. Vetalice

Spinal Elements was granted FDA 510(k) clearance for claims related to the macro-, micro- and nano-surface structure of its Ti-Bond® surface coating technology.

Ti-Bond is a hydrophilic porous titanium coating used at the bone-contacting endplates of the implant.

Spinal Elements’ utilizes Ti-Bond in a number of its products, including the most recently-introduced Lucent® XP expandable interbody device.

Sources: Spinal Elements; ORTHOWORLD, Inc.

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory