PMA
P070001: PRODISC TM-C TOTAL DISC REPLACEMENT
FDA PMA · Prosthesis, intervertebral disc · Centinel Spine, LLC
Key facts
| PMA number | P070001 |
|---|---|
| Trade name | PRODISC TM-C TOTAL DISC REPLACEMENT |
| Generic name | Prosthesis, intervertebral disc |
| Applicant | Centinel Spine, LLC |
| Owner/operator | Centinel Spine, LLC |
| Product code | MJO |
| Approval date | Dec 17, 2007 |
| Docket number | 08M-0013 |
| Notice date | Jan 10, 2008 |
| Establishment registration | 3007494564 |
| FEI number | 3007494564 |
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- No Withdrawn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: