MODIFICATION TO THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
Device Facts
| Record ID | K011380 |
|---|---|
| Device Name | MODIFICATION TO THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM |
| Applicant | Bioplate, Inc. |
| Product Code | JEY · Dental |
| Decision Date | May 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.
