Product code
QBO: Instruments designed for press-fit osteochondral implants
FDA product code · Class II · Orthopedic
Key facts
| Product code | QBO |
|---|---|
| Device | Instruments designed for press-fit osteochondral implants |
| Device class | Class II |
| Regulation number | 888.4505 |
| Review panel | Orthopedic |
| Medical specialty | Orthopedic |
| Submission type | 510(K) Exempt |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | The device is intended to manipulate bone and cartilage tissue or implant materials for the positioning, alignment, defect creation, or placement of press-fit osteochondral implants. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 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