SpineGuard Receives FDA 510(k) Clearance for Dynamic Surgical Guidance Device

By Julie A. Vetalice

SpineGuard received FDA 510(k) clearance to integrate the DSG™ (Dynamic Surgical Guidance) technology with U.S. partner Zavation’s pedicle screws. U.S. commercialization is expected to begin immediately.

The DSG technology is a combination of a bipolar sensor and pedicle screw, which allows the surgeon real-time guidance and the ability to insert the screw into a vertebra without drilling a pilot hole.

SpineGuard previously received FDA 510(k) clearance and CE Mark approval for the PediGuard Threaded DSG device. A third DSG-enabled screw was co-developed with Neuro France Implants and is in alpha launch in Europe with seven surgeons.

Sources: SpineGuard; ORTHOWORLD Inc.

Tags: 510(k) Clearance, Regulatory