Product code
MAX: Intervertebral fusion device with bone graft, lumbar
FDA product code · Class II · Orthopedic
Key facts
| Product code | MAX |
|---|---|
| Device | Intervertebral fusion device with bone graft, lumbar |
| Device class | Class II |
| Regulation number | 888.3080 |
| Review panel | Orthopedic |
| Medical specialty | Orthopedic |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | Yes |
| Life-sustaining or life-supporting | No |
| Definition | Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft. |
At a glance
- 100–999 510(k) clearances
- None De Novo grants
- 1–9 PMA approvals
- None HDE approvals
- 1,000+ UDI devices (GUDID)
- 1,000+ MAUDE adverse event reports
- 100–999 Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database