PMA
P810048: OSTEO CERAMIC HIP
FDA PMA · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented · Smith & Nephew, Inc.
Key facts
| PMA number | P810048 |
|---|---|
| Trade name | OSTEO CERAMIC HIP |
| Generic name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
| Applicant | Smith & Nephew, Inc. |
| Owner/operator | Smith & Nephew, Inc. |
| Product code | MRA |
| Approval date | Nov 5, 1982 |
| Docket number | 81M-0373 |
| Notice date | Dec 10, 1982 |
| Establishment registration | 1020279 |
| FEI number | 1020279 |
At a glance
- 10–99 Supplements
- May 10, 1988 Latest supplement decision
- Yes Withdrawn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: