PMA
P050010: PRODISC -L TOTAL DISC REPLACEMENT DEVICE
FDA PMA · Prosthesis, intervertebral disc · Centinel Spine, LLC
Key facts
| PMA number | P050010 |
|---|---|
| Trade name | PRODISC -L TOTAL DISC REPLACEMENT DEVICE |
| Generic name | Prosthesis, intervertebral disc |
| Applicant | Centinel Spine, LLC |
| Owner/operator | Centinel Spine, LLC |
| Product code | MJO |
| Approval date | Aug 14, 2006 |
| Docket number | 06M-0343 |
| Notice date | Aug 25, 2006 |
| Establishment registration | 3007494564 |
| FEI number | 3007494564 |
At a glance
- 10–99 Supplements
- Sep 2, 2025 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- No Withdrawn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: