PMA
N17113: OMNIPLASTIC BONE CEMENT
FDA PMA · BONE CEMENT · L.D. Caulk Co.
Key facts
| PMA number | N17113 |
|---|---|
| Trade name | OMNIPLASTIC BONE CEMENT |
| Generic name | BONE CEMENT |
| Applicant | L.D. Caulk Co. |
| Product code | LOD |
| Approval date | Sep 16, 1981 |
| Docket number | 81M-0308 |
| Notice date | Dec 4, 1981 |
At a glance
- None Supplements
- Sep 16, 1981 Latest supplement decision
- No Withdrawn
- No 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: