PMA
P960025: BRANTIGEN I/F CAGE(R) USED WITH VSP(R) SPINE PLATES AND PEDICLE SCREWS
FDA PMA · Intervertebral fusion device with bone graft, lumbar · Depuy Spine, Inc.
Key facts
| PMA number | P960025 |
|---|---|
| Trade name | BRANTIGEN I/F CAGE(R) USED WITH VSP(R) SPINE PLATES AND PEDICLE SCREWS |
| Generic name | Intervertebral fusion device with bone graft, lumbar |
| Applicant | Depuy Spine, Inc. |
| Owner/operator | DePuy Spine, Inc. |
| Product code | MAX |
| Approval date | Feb 2, 1999 |
| Docket number | 99M-0894 |
| Notice date | Apr 12, 1999 |
| Establishment registration | 1526439 |
| FEI number | 1526439 |
At a glance
- 10–99 Supplements
- Mar 17, 2004 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- No Withdrawn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: