PMA
P960047: OSTEONICS CONSTRAINED ACETABULAR INSERT
FDA PMA · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer · Howmedica Osteonics Corp.
Key facts
| PMA number | P960047 |
|---|---|
| Trade name | OSTEONICS CONSTRAINED ACETABULAR INSERT |
| Generic name | Prosthesis, hip, constrained, cemented or uncemented, metal/polymer |
| Applicant | Howmedica Osteonics Corp. |
| Owner/operator | STRYKER CORP. |
| Product code | KWZ |
| Approval date | Jun 13, 1997 |
| Docket number | 97M-0459 |
| Notice date | Nov 17, 1997 |
| Establishment registration | 2249697 |
| FEI number | 2243265 |
At a glance
- 1–9 Supplements
- Jul 25, 2001 Latest supplement decision
- No Withdrawn
- No 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: