NVR

Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar

Product code

NVR

Device name

Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar

Device class

Class 3

Medical specialty

Unknown

Marketing pathway

PMA

Flag

Implant

510(k) clearances (all years, FDA)

6 (all years; only the last 3 years are listed here)

FDA classification definition

Intended to be inserted between the vertebral bodies into the disc space from l3 to s1 to provide stabilization and to help promote intervertebral body fusion. To be used with bone graft, for holding bone parts in alignment while they heal. Not intended for use in motion-sparing, non-fusion procedures, helps promote intervertebral body fusion, please reference: https://www.federalregister.gov/documents/2023/03/30/2023-06566/medical-devices-orthopedic-devices-classification-of-spinal-spheres-for-use-in-intervertebral-fusion.

Definition text from the FDA device classification database (U.S. federal government work, public domain).