BIOSORBFX AND BIOSORBPDX MESH
Device Facts
| Record ID | K010687 |
|---|---|
| Device Name | BIOSORBFX AND BIOSORBPDX MESH |
| Applicant | Bionx Implants, Inc. |
| Product Code | JEY · Dental |
| Decision Date | Mar 14, 2001 |
| Decision | SESE |
| Submission Type | Special |
| 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.
