PMA
P020016: WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
FDA PMA · Joint, temporomandibular, implant · Biomet Microfixation, Inc.
Key facts
| PMA number | P020016 |
|---|---|
| Trade name | WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM |
| Generic name | Joint, temporomandibular, implant |
| Applicant | Biomet Microfixation, Inc. |
| Owner/operator | BIOMET MICROFIXATION |
| Product code | LZD |
| Approval date | Sep 21, 2005 |
| Docket number | 05M-0399 |
| Notice date | Oct 5, 2005 |
| Establishment registration | 1032347 |
| FEI number | 1032347 |
At a glance
- 10–99 Supplements
- Jul 27, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: