PMA
N17755: ZIMMER(R) BONE CEMENT
FDA PMA · BONE CEMENT · Zimmer, Inc.
Key facts
| PMA number | N17755 |
|---|---|
| Trade name | ZIMMER(R) BONE CEMENT |
| Generic name | BONE CEMENT |
| Applicant | Zimmer, Inc. |
| Owner/operator | ZIMMER, INC. |
| Product code | LOD |
| Approval date | May 17, 1976 |
| Establishment registration | 1822565 |
| FEI number | 1000220733 |
At a glance
- 10–99 Supplements
- Oct 28, 1997 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- No Withdrawn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: