Device Type ID | 4726 |
Device Name | Semi-constrained Metal/polymer Finger Joint Prosthesis |
Review Panel | Orthopedic |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Joint And Fixation Devices Branch Two ¿ Hips/Wrists/Fingers (JFDB2) |
Submission Type | HDE - Humanitarian Device Exem |
FDA Device Classification | Class HDE Medical Device |
Product Code | MPK |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
|
Device Type ID | 4726 |
Device | Semi-constrained Metal/polymer Finger Joint Prosthesis |
Product Code | MPK |
Device Problems | |
---|---|
Structural Problem | 1 |
Total Device Problems | 1 |