Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar
NVR · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
NVR
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
—
Review panel
OR
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N
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.