| Device Type ID | 5564 |
| Device Name | Appliance, Facial Fracture, External |
| Regulation Description | External Facial Fracture Fixation Appliance. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.3250 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | FYI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5564 |
| Device | Appliance, Facial Fracture, External |
| Product Code | FYI |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | External Facial Fracture Fixation Appliance. |
| CFR Regulation Number | 878.3250 [🔎] |