PMA
P250042: BAGUERA®C Cervical Disc Prosthesis
FDA PMA · Prosthesis, intervertebral disc · Spineart USA, Inc.
Key facts
| PMA number | P250042 |
|---|---|
| Trade name | BAGUERA®C Cervical Disc Prosthesis |
| Generic name | Prosthesis, intervertebral disc |
| Applicant | Spineart USA, Inc. |
| Product code | MJO |
| Approval date | Aug 10, 2026 |
At a glance
- 1–9 Supplements
- Sep 22, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: