PMA
P000028: AFFINITY (TM) CAGE SYSTEM
FDA PMA · Intervertebral fusion device with bone graft, lumbar · Medtronic Sofamor Danek USA, Inc.
Key facts
| PMA number | P000028 |
|---|---|
| Trade name | AFFINITY (TM) CAGE SYSTEM |
| Generic name | Intervertebral fusion device with bone graft, lumbar |
| Applicant | Medtronic Sofamor Danek USA, Inc. |
| Owner/operator | Medtronic, Inc. |
| Product code | MAX |
| Approval date | Jun 13, 2002 |
| Docket number | 03M-0532 |
| Notice date | Nov 24, 2003 |
| Establishment registration | 1030489 |
| FEI number | 1000477302 |
At a glance
- 1–9 Supplements
- Jul 25, 2006 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- No Withdrawn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: