NVR · Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar
· Class 3
Overview
| Product Code | NVR |
|---|---|
| Device Name | Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar |
| Device Class | Class 3 |
| Review Panel | |
| Implant | Yes |
Identification
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.
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K073274 | SPINAL SPHERE SYSTEM | Life Spine | Mar 17, 2008 | SESU |
| K073105 | PEEK SPINAL SPHERES | Interbody Innovations, Llp | Jan 3, 2008 | SESU |
| K062992 | SPINAL SPHERES | Interbody Innovations, Llp | Jul 27, 2007 | SESU |
| K063139 | SPINAL STABILIZING SPHERE SYSTEM | Biomet Spine | Apr 4, 2007 | SESU |
| K060415 | MODIFICATION TO: SATELLITE SPINAL SYSTEM | Medtronic Sofamor Danek | Jan 5, 2007 | SESU |
| K051320 | SATELLITE SPINAL SYSTEM | Medtronic Sofamor Danek | Sep 9, 2005 | SESU |
Top Applicants
- Interbody Innovations, Llp — 2 clearances
- Medtronic Sofamor Danek — 2 clearances
- Biomet Spine — 1 clearance
- Life Spine — 1 clearance
