PMA
P850035: SpF® Implantable Spinal Fusion Stimulator
FDA PMA · Stimulator, invasive bone growth · Ahp Eos Buyer, Inc.
Key facts
| PMA number | P850035 |
|---|---|
| Trade name | SpF® Implantable Spinal Fusion Stimulator |
| Generic name | Stimulator, invasive bone growth |
| Applicant | Ahp Eos Buyer, Inc. |
| Owner/operator | EBI, LLC - AHP EOS Buyer Inc. |
| Product code | LOE |
| Approval date | Apr 30, 1987 |
| Docket number | 87M-0174 |
| Notice date | Jun 10, 1987 |
| Establishment registration | 2242816 |
| FEI number | 2242816 |
At a glance
- 10–99 Supplements
- Sep 20, 2024 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- No Withdrawn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: