NEWGEN SYSTEM
Device Facts
| Record ID | K002619 |
|---|---|
| Device Name | NEWGEN SYSTEM |
| Applicant | Stryker Instruments |
| Product Code | JEY · Dental |
| Decision Date | Nov 16, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.4760 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.
