Product code
PBF: Orthopaedic surgical planning and instrument guides
FDA product code · Class II · Orthopedic
Key facts
| Product code | PBF |
|---|---|
| Device | Orthopaedic surgical planning and instrument guides |
| Device class | Class II |
| Regulation number | 888.3030 |
| Review panel | Orthopedic |
| Medical specialty | Orthopedic |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | As a surgical instrument to assist in pre-operative planning and/or guiding the marking of bone and/or guide surgical instruments for orthopedic surgical procedures. |
At a glance
- 10–99 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1,000+ UDI devices (GUDID)
- 100–999 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