Nexxt Spine - FDA 510(k) Cleared Devices

Nexxt Spine, designs and manufactures spinal implants and instruments at its state-of-the-art facility in Noblesville, Indiana. The company specializes in 3D printed titanium interbodies, plating systems, pedicle screw systems, and related surgical instruments for spinal procedures. Since 2009, Nexxt Spine has maintained in-house manufacturing of 100% of implants and 95% of instruments.

Nexxt Spine has received 2 FDA 510(k) clearances from 2 total submissions, with all submissions focused on Orthopedic devices. The company's regulatory activity spans 2024 to 2025, with the most recent clearance in 2025, demonstrating continued innovation and market engagement.

The company's cleared device portfolio includes the NEXXT MATRIXX® SI System and STRUXXURE® MCS Anterior Cervical Plate System, both representing advances in spinal fixation and interbody fusion technologies. Nexxt Spine has been recognized as one of Indiana's Best Places to Work in Manufacturing for three consecutive years and ranks among the state's largest medical device developers.

Explore the complete regulatory record, including device names, product codes, and clearance dates, in the FDA 510(k) database.

510(k) submissions have been managed by Empirical Technologies as regulatory consultant.