PMA
P850007: PHYSIO-STIM(TM) I & II MODEL 6000 & 7000
FDA PMA · Stimulator, bone growth, non-invasive · Orthofix, Inc.
Key facts
| PMA number | P850007 |
|---|---|
| Trade name | PHYSIO-STIM(TM) I & II MODEL 6000 & 7000 |
| Generic name | Stimulator, bone growth, non-invasive |
| Applicant | Orthofix, Inc. |
| Owner/operator | Orthofix US LLC |
| Product code | LOF |
| Approval date | Feb 21, 1986 |
| Docket number | 86M-0138 |
| Notice date | Apr 18, 1986 |
| Establishment registration | 2183449 |
| FEI number | 2183449 |
At a glance
- 10–99 Supplements
- Jun 14, 2022 Latest supplement decision
- No Withdrawn
- No 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: