| Device Type ID | 4594 |
| Device Name | Instrument, Cast Application/removal, Manual |
| Regulation Description | Manual Cast Application And Removal Instrument. |
| 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) Exempt |
| CFR Regulation Number | 888.5980 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | LGG |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4594 |
| Device | Instrument, Cast Application/removal, Manual |
| Product Code | LGG |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Cast Application And Removal Instrument. |
| CFR Regulation Number | 888.5980 [🔎] |