ZURICH PEDIATRIC MAXILLARY DISTRACTOR, MODELS 51-550-15 AND 51-551-15
Device Facts
| Record ID | K000580 |
|---|---|
| Device Name | ZURICH PEDIATRIC MAXILLARY DISTRACTOR, MODELS 51-550-15 AND 51-551-15 |
| Applicant | KLS-Martin L.P. |
| Product Code | MQN · Dental |
| Decision Date | Jul 24, 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.