PMA
P040051: STELKAST SURPASS ACETABULAR SYSTEM
FDA PMA · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented · Stelkast Company
Key facts
| PMA number | P040051 |
|---|---|
| Trade name | STELKAST SURPASS ACETABULAR SYSTEM |
| Generic name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
| Applicant | Stelkast Company |
| Product code | MRA |
| Approval date | May 12, 2006 |
| Docket number | 07M-0109 |
| Notice date | Mar 26, 2007 |
At a glance
- 1–9 Supplements
- Apr 22, 2011 Latest supplement decision
- Yes Withdrawn
- Yes 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: