Device Type ID | 4707 |
Device Name | Ligaments And Tendons, Synthetic |
Review Panel | Orthopedic |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Restorative And Repair Devices Branch (RRDB) |
Submission Type | PMA |
FDA Device Classification | Class 3 Medical Device |
Product Code | LML |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 4707 |
Device | Ligaments And Tendons, Synthetic |
Product Code | LML |
FDA Device Classification | Class 3 Medical Device |