PMA
P230025: Xstim Spine Fusion Stimulator
FDA PMA · Stimulator, bone growth, non-invasive · Xstim, Inc.
Key facts
| PMA number | P230025 |
|---|---|
| Trade name | Xstim Spine Fusion Stimulator |
| Generic name | Stimulator, bone growth, non-invasive |
| Applicant | Xstim, Inc. |
| Owner/operator | Xstim Inc. |
| Product code | LOF |
| Approval date | Feb 9, 2024 |
| Docket number | 24M-0782 |
| Notice date | Feb 21, 2024 |
| Establishment registration | 3030686063 |
| FEI number | 3030686063 |
At a glance
- 1–9 Supplements
- Nov 12, 2024 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: