PMA
P050009: C2 A-TAPER ACETABULAR SYSTEM
FDA PMA · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented · Biomet, Inc.
Key facts
| PMA number | P050009 |
|---|---|
| Trade name | C2 A-TAPER ACETABULAR SYSTEM |
| Generic name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
| Applicant | Biomet, Inc. |
| Owner/operator | Zimmer Inc |
| Product code | MRA |
| Approval date | Dec 16, 2005 |
| Docket number | 06M-0015 |
| Notice date | Jan 13, 2006 |
| Establishment registration | 1825034 |
| FEI number | 1825034 |
At a glance
- 1–9 Supplements
- Feb 11, 2011 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- Yes Withdrawn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: