Product code
PPT: Cranial surgical planning and instrument guides
FDA product code · Class II · Neurology
Key facts
| Product code | PPT |
|---|---|
| Device | Cranial surgical planning and instrument guides |
| Device class | Class II |
| Regulation number | 882.4310 |
| Review panel | Neurology |
| Medical specialty | Neurology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Software and hardware for surgical planning to create patient-specific anatomical models, surgical templates, and guides for use in the marking or cutting of cranial bone for neurosurgical procedures. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- None MAUDE adverse event reports
- None 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