Spinal Elements Gains FDA Clearance of Sapphire X Anterior Cervical Fixation

By Julie A. Vetalice

Spinal Elements Gains FDA Clearance of Sapphire X Anterior Cervical Fixation

Spinal Elements received FDA 510(k) clearance to market the Sapphire® X for anterior cervical fixation. Commercial launch is slated for coming months.

Sapphire X features integrated instrumentation and high angulation screws designed to help preserve the patient’s skeletal and muscle tissue. Post-op, the low-overhang implant is designed to minimize disruption to the patient’s nearby healthy anatomy.

“We are thrilled that Sapphire X, another organically developed MIS Ultra solution, is one step closer to clinical use and commercial introduction,” stated Jason Blain, President and CEO. “We believe Sapphire X has the potential to improve the intra-operative experience while reducing long-term adjacent level degeneration, one of the recognized unintended consequences in this application.”

Spinal Elements announced its MIS Ultra platform in June of this year.

Product Labels: Cervical Spine, Spinal Fusion

Tags: 510(k) Clearance, Regulatory