NVR — Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar Class III
Classification Details
- Product Code
- NVR
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Unknown
- Implant
- Yes
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K073274 | life spine | SPINAL SPHERE SYSTEM | March 17, 2008 |
| K073105 | interbody innovations | PEEK SPINAL SPHERES | January 3, 2008 |
| K062992 | interbody innovations | SPINAL SPHERES | July 27, 2007 |
| K063139 | biomet spine | SPINAL STABILIZING SPHERE SYSTEM | April 4, 2007 |
| K060415 | medtronic sofamor danek | MODIFICATION TO: SATELLITE SPINAL SYSTEM | January 5, 2007 |
| K051320 | medtronic sofamor danek | SATELLITE SPINAL SYSTEM | September 9, 2005 |