Regulatory Clearances for NEO Pedicle Screw with BonOs Inject Cement

By Julie A. Vetalice

Regulatory Clearances for NEO Pedicle Screw with BonOs Inject Cement

Neo Medical received FDA 510(k) clearance for the use of its Pedicle Screw System in late stage tumor indications in combination with BonOs® Inject cement from OSARTIS. This additional FDA 510(k) clearance for the system enables U.S. surgeons to take full advantage of Neo universal screw design and offer their patients the optimal treatment option when screw augmentation is desirable in this indication.

Second, next to the FDA 510(k) clearance, the company also obtained CE certification for its 8.0mm screws, iliac screws and connectors, as well as rod-to-rod connectors, thereby completing the universal offering of the Neo Pedicle Screw System.

Vincent Lefauconnier, Neo Medical CEO, said, "The FDA 510(k) clearance and CE certification announced today come as we continue to expand our portfolio and develop new applications for NEO pedicle Screw system. The rest of the year should see the company continuing to expand its activities, including in the digital space with the roll-out of groundbreaking augmented reality solutions to complement our existing platform of physical products."

Source: Neo Medical

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, CE Mark, Regulatory