PMA
P210035: AccelStimTM Bone Growth Stimulator
FDA PMA · Stimulator, bone growth, non-invasive · Orthofix US, LLC
Key facts
| PMA number | P210035 |
|---|---|
| Trade name | AccelStimTM Bone Growth Stimulator |
| Generic name | Stimulator, bone growth, non-invasive |
| Applicant | Orthofix US, LLC |
| Owner/operator | Orthofix US LLC |
| Product code | LOF |
| Approval date | May 3, 2022 |
| Docket number | 22M-0751 |
| Notice date | May 6, 2022 |
| Establishment registration | 2183449 |
| FEI number | 2183449 |
At a glance
- 1–9 Supplements
- Mar 21, 2025 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- No Withdrawn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: