| Device Type ID | 4569 |
| Device Name | Appliance, Nail/blade/plate Combination, Single Component |
| Regulation Description | Single/multiple Component Metallic Bone Fixation Appliances And Accessories. |
| Regulation Medical Specialty | Orthopedic |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE)
Division Of Orthopedic Devices (DOD)
Joint And Fixation Devices Branch One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 888.3030 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KWK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |