PMA
P970015: INTER FIX THREADED FUSION DEVICE
FDA PMA · Intervertebral fusion device with bone graft, lumbar · Sofamor Danek
Key facts
| PMA number | P970015 |
|---|---|
| Trade name | INTER FIX THREADED FUSION DEVICE |
| Generic name | Intervertebral fusion device with bone graft, lumbar |
| Applicant | Sofamor Danek |
| Owner/operator | Medtronic, Inc. |
| Product code | MAX |
| Approval date | May 14, 1999 |
| Docket number | 99M-4277 |
| Establishment registration | 1030489 |
| FEI number | 1000477302 |
At a glance
- 10–99 Supplements
- Jul 27, 2005 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- No Withdrawn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: