PMA
P000023: TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESES
FDA PMA · Joint, temporomandibular, implant · Nexus CMF, LLC
Key facts
| PMA number | P000023 |
|---|---|
| Trade name | TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESES |
| Generic name | Joint, temporomandibular, implant |
| Applicant | Nexus CMF, LLC |
| Owner/operator | Nexus CMF |
| Product code | LZD |
| Approval date | Jan 5, 2001 |
| Docket number | 01M-0255 |
| Notice date | Jun 11, 2001 |
| Establishment registration | 3009702671 |
| FEI number | 3009702671 |
At a glance
- 10–99 Supplements
- Feb 13, 2015 Latest supplement decision
- No Withdrawn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: