CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM
Device Facts
| Record ID | K010352 |
|---|---|
| Device Name | CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM |
| Applicant | Inion , Ltd. |
| Product Code | JEY · Dental |
| Decision Date | Mar 14, 2001 |
| 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.
