PMA
P910066: ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR
FDA PMA · Stimulator, bone growth, non-invasive · Djo, LLC
Key facts
| PMA number | P910066 |
|---|---|
| Trade name | ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR |
| Generic name | Stimulator, bone growth, non-invasive |
| Applicant | Djo, LLC |
| Owner/operator | DJO, LLC |
| Product code | LOF |
| Approval date | Mar 4, 1994 |
| Docket number | 94M-0128 |
| Notice date | May 20, 1994 |
| Establishment registration | 3012446970 |
| FEI number | 2020737 |
At a glance
- 10–99 Supplements
- Jan 23, 2020 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 1–9 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: