PMA supplement
P950019 S009: RAY TFC DEVICE AND RAY TFC UNITE DEVICE
FDA PMA supplement · Panel Track · Stryker Spine
Key facts
| Original PMA | P950019 |
|---|---|
| Supplement number | S009 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | RAY TFC DEVICE AND RAY TFC UNITE DEVICE |
| Generic name | Intervertebral fusion device with bone graft, lumbar |
| Applicant | Stryker Spine |
| Product code | MAX |
| Received date | May 3, 1999 |
| Decision date | Mar 2, 2000 |
| Docket number | 00M-1212 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: