NanoHive Medical, LLC - FDA 510(k) Cleared Devices

NanoHive Medical, LLC designs and manufactures bioactive spinal fusion interbody devices with a manufacturing facility in Woburn, Massachusetts. The company specializes in 3D printed titanium implants featuring proprietary Soft Titanium® technology and a patented rhombic dodecahedron lattice structure.

NanoHive has received 3 FDA 510(k) clearances from 3 total submissions since 2022. All submissions focus on Orthopedic devices for spinal fusion applications. The company remains active, with its most recent clearance in 2026.

The company's product portfolio includes standalone cervical systems, cervical interbody devices, and lumbar interbody systems for anterior, posterior, and thoracolumbar approaches. NanoHive's technology aims to reduce implant stiffness while maintaining load-bearing strength comparable to bone.

Explore the complete list of cleared device names, product codes, and clearance dates in the 510(k) database.

Regulatory submissions have been managed by Empirical Technologies and Applied Technical Services (Empirical Technologies).