PMA
P220031: LimiFlex Dynamic Sagittal Tether
FDA PMA · Prosthesis, spinous process tension band implant · Empirical Spine, Inc.
Key facts
| PMA number | P220031 |
|---|---|
| Trade name | LimiFlex Dynamic Sagittal Tether |
| Generic name | Prosthesis, spinous process tension band implant |
| Applicant | Empirical Spine, Inc. |
| Owner/operator | Empirical Spine, Inc. |
| Product code | SGK |
| Approval date | Feb 12, 2026 |
| Docket number | FDA-1892 |
| Notice date | Feb 20, 2026 |
| Establishment registration | 3013114075 |
| FEI number | 3013114075 |
At a glance
- 1–9 Supplements
- Apr 8, 2026 Latest supplement decision
- No Withdrawn
- Yes 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: