PMA
P040023: DURALOC OPTION CERAMIC HIP SYSTEM
FDA PMA · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented · DePuy Orthopaedics, Inc.
Key facts
| PMA number | P040023 |
|---|---|
| Trade name | DURALOC OPTION CERAMIC HIP SYSTEM |
| Generic name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
| Applicant | DePuy Orthopaedics, Inc. |
| Owner/operator | DePuy Synthes, Inc. |
| Product code | MRA |
| Approval date | May 3, 2005 |
| Docket number | 06M-0512 |
| Notice date | Dec 20, 2006 |
| Establishment registration | 1818910 |
| FEI number | 1818910 |
At a glance
- 10–99 Supplements
- Nov 20, 2012 Latest supplement decision
- Yes Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: