CTL Gains FDA Approval for Seurat Pedicle Screw

By Julie A. Vetalice

CTL Medical received FDA 510(k) clearance to market the SEURAT Universal Pedicle Screw. The product is slated for 2H18 launch.

SEURAT includes features from each of the company's already-cleared pedicle screw systems. A modular housing assembly option and choice of standard or reinforced-ring locking set screw allows the surgeon to customize the implant per patient needs. Further, the system includes polyaxial and monoaxial, open and MIS, single and dual thread profile, solid and cannulated and hex and hexalobe screws of all diameters and lengths.

Source: CTL Medical Corporation


Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory