OrthoPediatrics Gains FDA Clearance for Next-Generation Cannulated Screw

By Julie A. Vetalice

OrthoPediatrics was granted FDA 510(k) clearance to market its next-generation Cannulated Screw to treat smaller stature patients with fractures and fusions. The system is slated for launch in 3Q19.

The new screws are stainless steel and available in 2.5mm, 3.0mm, 3.5mm, 4.0mm, 4.5mm and 5.5mm sizes, and are accompanied by an “all-in-one” kit option to support O.R. efficiency.

Source: OrthoPediatrics Corp.

Product Labels: Upper Extremity, Lower Extremity

Tags: 510(k) Clearance, Regulatory