Cutting Edge Spine, LLC - FDA 510(k) Cleared Devices

Cutting Edge Spine, LLC develops and commercializes spinal implant systems with a focus on bioactive materials and trabecular fixation technologies. Headquartered in North Carolina, the company was founded in 2009 and operates with a manufacturing facility in Waxhaw, US.

The company has received 11 FDA 510(k) clearances from 11 total submissions since 2011. All submissions focus on Orthopedic devices, including cervical and lumbar interbody fusion systems and sacroiliac joint fixation platforms. The latest clearance in 2025 confirms the company remains active in device development and commercialization.

Cutting Edge Spine specializes in passively smart spinal implant systems featuring advanced technologies such as hydroxyapatite-enhanced materials, trabecular fixation architecture, and 3D-printed implant designs. The company holds an extensive patent portfolio for trabecular fixation across orthopedic applications and was first to market in the U.S. with several bioactive material innovations for spinal surgery.

Explore the complete list of cleared device names, product codes, and clearance dates in the database.