PMA
N17004: SURGICAL SIMPLEX P RADEOPAQUE BONE CEMENT
FDA PMA · BONE CEMENT · Howmedica Corp.
Key facts
| PMA number | N17004 |
|---|---|
| Trade name | SURGICAL SIMPLEX P RADEOPAQUE BONE CEMENT |
| Generic name | BONE CEMENT |
| Applicant | Howmedica Corp. |
| Owner/operator | STRYKER CORP. |
| Product code | LOD |
| Approval date | Oct 7, 1971 |
| Establishment registration | 1811755 |
| FEI number | 1811755 |
At a glance
- 10–99 Supplements
- Dec 15, 2000 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- No Withdrawn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: