JAW FIXATION ASSEMBLY
Device Facts
| Record ID | K863799 |
|---|---|
| Device Name | JAW FIXATION ASSEMBLY |
| Applicant | Medical Products & Research, Inc. |
| Product Code | DYX · Dental |
| Decision Date | Oct 14, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.4600 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An intraoral ligature and wire lock is a metal device intended to constrict fractured bone segments in the oral cavity. The bone segments are stabilized by wrapping the ligature (wire) around the fractured bone segments and locking the ends together.
