Novapproach Spine, LLC - FDA 510(k) Cleared Devices

Novapproach Spine, LLC develops orthopedic implants and surgical approaches for anterior lumbar spine fusion. Based in Alachua, Florida, the company specializes in simplifying single-position spine surgery through innovative cage and fixation technologies.

The company has received 1 FDA 510(k) clearance from 1 total submission. Novapproach Spine focuses exclusively on orthopedic devices, with its first and latest clearance in 2025. The company remains active in regulatory submissions and commercialization.

The cleared device, OneLIF™ Interbody Fusion System, supports multiple anterior lumbar approaches including ALIF, SupineATP®, and Lateral ATP procedures. The system features patented Multi-Fix™ fixation design for flexible screw placement across varying patient anatomies.

Explore the company's device names, product codes, and clearance dates in the full 510(k) database record.

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