PMA
P220002: TOPS™ System
FDA PMA · Prosthesis, posterior spinal elements · Premia Spine, Ltd.
Key facts
| PMA number | P220002 |
|---|---|
| Trade name | TOPS™ System |
| Generic name | Prosthesis, posterior spinal elements |
| Applicant | Premia Spine, Ltd. |
| Owner/operator | Premia Spine Ltd. |
| Product code | QWK |
| Approval date | Jun 15, 2023 |
| Docket number | 23M-2945 |
| Notice date | Jul 21, 2023 |
| Establishment registration | 3012401682 |
| FEI number | 3012401682 |
At a glance
- 10–99 Supplements
- Sep 9, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 100–999 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: