PMA
P100003: SECURE-C ARTIFICIAL CERVICAL DISC
FDA PMA · Prosthesis, intervertebral disc · Globus Medical, Inc.
Key facts
| PMA number | P100003 |
|---|---|
| Trade name | SECURE-C ARTIFICIAL CERVICAL DISC |
| Generic name | Prosthesis, intervertebral disc |
| Applicant | Globus Medical, Inc. |
| Owner/operator | GLOBUS MEDICAL, INC. |
| Product code | MJO |
| Approval date | Sep 28, 2012 |
| Docket number | 12M-1039 |
| Notice date | Oct 2, 2012 |
| Establishment registration | 3004142400 |
| FEI number | 3004142400 |
At a glance
- 1–9 Supplements
- Jun 12, 2023 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- No Withdrawn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: