Device Type ID | 4717 |
Device Name | Prosthesis, Knee, Patello/femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
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 | PMA |
FDA Device Classification | Class 3 Medical Device |
Product Code | MBD |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 4717 |
Device | Prosthesis, Knee, Patello/femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
Product Code | MBD |
FDA Device Classification | Class 3 Medical Device |
Device Problems | |
---|---|
Insufficient Information | 1 |
Fracture | 1 |
Total Device Problems | 2 |