PMA
P050016: CORMET HIP RESURFACING SYSTEM
FDA PMA · Prosthesis, hip, semi-constrained, metal/metal, resurfacing · Corin USA
Key facts
| PMA number | P050016 |
|---|---|
| Trade name | CORMET HIP RESURFACING SYSTEM |
| Generic name | Prosthesis, hip, semi-constrained, metal/metal, resurfacing |
| Applicant | Corin USA |
| Owner/operator | Corin Group |
| Product code | NXT |
| Approval date | Jul 3, 2007 |
| Docket number | 07M-0286 |
| Notice date | Jul 20, 2007 |
| Establishment registration | 9614209 |
| FEI number | 3002806725 |
At a glance
- 10–99 Supplements
- Jul 17, 2020 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- No Withdrawn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: