MICRO OSTEOSYNTHESIS SYSTEM (1.0)
Device Facts
| Record ID | K944561 |
|---|---|
| Device Name | MICRO OSTEOSYNTHESIS SYSTEM (1.0) |
| Applicant | KLS-Martin L.P. |
| Product Code | JEY · Dental |
| Decision Date | Oct 18, 1994 |
| 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.