| Device Type ID | 4718 |
| Device Name | Fastener, Fixation, Biodegradable, Hard Tissue |
| 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 | Contact ODE |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | MBJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4718 |
| Device | Fastener, Fixation, Biodegradable, Hard Tissue |
| Product Code | MBJ |
| FDA Device Classification | Class 3 Medical Device |