# Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar
> **Product code: 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.

## Market data
- **Cleared 510(k) submissions:** 6
- **Registered establishments:** 4
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NVR)
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