Product code
OSF: Patient specific manual orthopedic stereotaxic system
FDA product code · Class II · Orthopedic
Key facts
| Product code | OSF |
|---|---|
| Device | Patient specific manual orthopedic stereotaxic system |
| Device class | Class II |
| Regulation number | 882.4560 |
| Review panel | Orthopedic |
| Medical specialty | Neurology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Intended for defining orthopedic acetabular implant alignment relative to a patient's anatomy. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- None UDI devices (GUDID)
- None MAUDE adverse event reports
- 1–9 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