NVR

6 FDA 510(k) clearances · Product code

FDA profile

Official device name

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

Device class

Class III (high risk)

Medical specialty

Unknown

Flags

Implant

FDA 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.

Adverse events (MAUDE)

2007: 4 · 2008: 9 · 2009: 5
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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