SCREW, BONE, MAXILLOFACIAL
Device Facts
| Record ID | K911165 |
|---|---|
| Device Name | SCREW, BONE, MAXILLOFACIAL |
| Applicant | Tekno-Medical |
| Product Code | DZL · Dental |
| Decision Date | Aug 20, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.4880 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.