PMA
N980003: KERAMOS CERAMIC/CERAMIC TOTAL HIP SYSTEM
FDA PMA · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented · Djo Surgical
Key facts
| PMA number | N980003 |
|---|---|
| Trade name | KERAMOS CERAMIC/CERAMIC TOTAL HIP SYSTEM |
| Generic name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
| Applicant | Djo Surgical |
| Owner/operator | ENCORE MEDICAL, L.P. |
| Product code | MRA |
| Approval date | Nov 26, 2003 |
| Establishment registration | 1644408 |
| FEI number | 1000116912 |
At a glance
- 1–9 Supplements
- Feb 13, 2009 Latest supplement decision
- Yes Withdrawn
- No 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: