PMA
P050039: NOVATION CERAMIC ARTICULATION HIP SYSTEM
FDA PMA · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented · Exactech, Inc.
Key facts
| PMA number | P050039 |
|---|---|
| Trade name | NOVATION CERAMIC ARTICULATION HIP SYSTEM |
| Generic name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
| Applicant | Exactech, Inc. |
| Owner/operator | EXACTECH, INC. |
| Product code | MRA |
| Approval date | Jul 5, 2007 |
| Docket number | 07M-0287 |
| Notice date | Jul 20, 2007 |
| Establishment registration | 1038671 |
| FEI number | 1038671 |
At a glance
- 10–99 Supplements
- Apr 3, 2017 Latest supplement decision
- Yes Withdrawn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: