PMA
P960053: BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS
FDA PMA · Prosthesis, finger, constrained, metal/polymer · Stryker Corporation
Key facts
| PMA number | P960053 |
|---|---|
| Trade name | BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS |
| Generic name | Prosthesis, finger, constrained, metal/polymer |
| Applicant | Stryker Corporation |
| Owner/operator | STRYKER CORP. |
| Product code | KWG |
| Approval date | Jun 19, 1997 |
| Docket number | 97M-0393 |
| Notice date | Sep 23, 1997 |
| Establishment registration | 1811755 |
| FEI number | 1811755 |
At a glance
- 1–9 Supplements
- Aug 9, 2016 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- No Withdrawn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: