PMA
P850022: Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System; Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator Sy
FDA PMA · Stimulator, bone growth, non-invasive · Ahp Eos Buyer, Inc.
Key facts
| PMA number | P850022 |
|---|---|
| Trade name | Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System; Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator Sy |
| Generic name | Stimulator, bone growth, non-invasive |
| Applicant | Ahp Eos Buyer, Inc. |
| Owner/operator | EBI, LLC - AHP EOS Buyer Inc. |
| Product code | LOF |
| Approval date | Feb 18, 1986 |
| Docket number | 86M-0139 |
| Notice date | Apr 9, 1986 |
| Establishment registration | 2242816 |
| FEI number | 2242816 |
At a glance
- 10–99 Supplements
- Feb 29, 2024 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- No Withdrawn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: