Elevation Spine - FDA 510(k) Cleared Devices

Elevation Spine, develops spinal fusion systems designed to enable less invasive surgical approaches. The company operates with a manufacturing facility in Monterey, California.

Elevation Spine has received 3 FDA 510(k) clearances from 3 total submissions since 2019. The company specializes exclusively in Orthopedic devices for spinal surgery. The latest clearance in 2026 reflects continued regulatory activity and product development.

The SABER-C System represents the company's core offering-a zero-profile anterior cervical plate system that combines plate, interbody, and fixation components. The system features proprietary spike fixation technology alongside traditional screw options, enabling surgical flexibility for cervical fusion procedures.

Explore the complete regulatory history, device names, product codes, and clearance dates in the database.

510(k) submissions have been managed by MRC Global, LLC as regulatory consultant.