PMA supplement
N980003 S007: KERAMOS CERAMIC/CERAMIC TOTAL HIP SYSTEM
FDA PMA supplement · Normal 180 Day Track · Djo Surgical
Key facts
| Original PMA | N980003 |
|---|---|
| Supplement number | S007 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | KERAMOS CERAMIC/CERAMIC TOTAL HIP SYSTEM |
| Generic name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
| Applicant | Djo Surgical |
| Product code | MRA |
| Received date | May 6, 2008 |
| Decision date | Feb 13, 2009 |
At a glance
- No Expedited review granted
- No Approval order on file
- No 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: