FDA product code NVR: Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar
NVR is the FDA product code for intervertebral fusion device with bone graft, solid-sphere, lumbar. It is a Class III device, reviewed by the Orthopedic panel. FDA has cleared 6 510(k) submissions under NVR, from 4 different applicants. The average 510(k) review took 180 days (median 144). FDA has posted 17 recalls for NVR devices.
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.
Classification
| Field | Value |
|---|---|
| Device name | Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar |
| Device class | Class III |
| Review panel | OR — Orthopedic |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Compare with all 510(k) review times · Search every NVR clearance
Top NVR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Interbody Innovations, Llp | 2 | 2008-01-03 |
| Medtronic Sofamor Danek | 2 | 2007-01-05 |
| Life Spine | 1 | 2008-03-17 |
| Biomet Spine | 1 | 2007-04-04 |
Most recent NVR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K073274 | Life Spine | SPINAL SPHERE SYSTEM | 2008-03-17 | 117 |
| K073105 | Interbody Innovations, Llp | PEEK SPINAL SPHERES | 2008-01-03 | 62 |
| K062992 | Interbody Innovations, Llp | SPINAL SPHERES | 2007-07-27 | 298 |
| K063139 | Biomet Spine | SPINAL STABILIZING SPHERE SYSTEM | 2007-04-04 | 170 |
| K060415 | Medtronic Sofamor Danek | MODIFICATION TO: SATELLITE SPINAL SYSTEM | 2007-01-05 | 322 |
Recalls for NVR devices
17 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2007-09-13.
Frequently asked questions
What is FDA product code NVR?
NVR is the FDA product code for intervertebral fusion device with bone graft, solid-sphere, lumbar. It is a Class III device, reviewed by the Orthopedic panel.
What device class is NVR?
Class III. Typical premarket route: PMA.
How long does a 510(k) take for product code NVR?
Across 6 cleared submissions the average was 180 days from receipt to decision (median 144).
Which companies have the most NVR clearances?
Interbody Innovations, Llp (2); Medtronic Sofamor Danek (2); Life Spine (1); Biomet Spine (1).
Have NVR devices been recalled?
Yes: 17 product recalls across 1 recall events; the most recent began 2007-09-13.
Next steps
- Run an FDA pathway report with predicate devices for product code NVR
- Run a recall and safety report across every NVR manufacturer
- Watch product code NVR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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