Home » Vallum Awarded 510(k) Clearance for Nanotextured Spinal Interbody Fusion Device
Vallum Awarded 510(k) Clearance for Nanotextured Spinal Interbody Fusion Device
Devices Submissions and Approvals
Vallum received 510(k) clearance for its polyetheretherketone PEEKplus nanotextured spinal interbody fusion device, which uses nanotexturing to improve bone fusion and growth.
The surface promotes osteoblast functions needed to grow bone and encourages fusion by generating osteogenic responses.
The nanotexturing can be applied to any PEEK device without impacting its design or size.
Nanotexturing has the potential to set “a new standard in the performance of spinal fusion interbody implants,” according to Eric J. Woodard, chairman of Vallum’s medical advisory board.