PMA
P950019: RAY THREADED FUSION CAGE (TFC)(TM) WITH INSTRUMENTATION
FDA PMA · Intervertebral fusion device with bone graft, lumbar · Stryker Spine
Key facts
| PMA number | P950019 |
|---|---|
| Trade name | RAY THREADED FUSION CAGE (TFC)(TM) WITH INSTRUMENTATION |
| Generic name | Intervertebral fusion device with bone graft, lumbar |
| Applicant | Stryker Spine |
| Owner/operator | VB Spine, LLC |
| Product code | MAX |
| Approval date | Oct 29, 1996 |
| Docket number | 97M-0052 |
| Notice date | Mar 3, 1997 |
| Establishment registration | 3004024955 |
| FEI number | 3004024955 |
At a glance
- 10–99 Supplements
- Mar 25, 2004 Latest supplement decision
- No Withdrawn
- No 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: