PMA
P250028: Synergy Disc
FDA PMA · Prosthesis, intervertebral disc · Synergy Spine Solutions, Inc.
Key facts
| PMA number | P250028 |
|---|---|
| Trade name | Synergy Disc |
| Generic name | Prosthesis, intervertebral disc |
| Applicant | Synergy Spine Solutions, Inc. |
| Owner/operator | Synergy Spine Solutions Inc. |
| Product code | MJO |
| Approval date | Feb 26, 2026 |
| Docket number | 26M-2123 |
| Notice date | Feb 27, 2026 |
| Establishment registration | 3014213973 |
| FEI number | 3014213973 |
At a glance
- 1–9 Supplements
- Sep 17, 2026 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- No Withdrawn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: