Device Type ID | 4592 |
Device Name | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Trunnion-bearing |
Regulation Description | Knee Joint Femorotibial Metal/polymer Semi-constrained Cemented Prosthesis. |
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) |
CFR Regulation Number | 888.3530 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | LGE |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 4592 |
Device | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Trunnion-bearing |
Product Code | LGE |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Knee Joint Femorotibial Metal/polymer Semi-constrained Cemented Prosthesis. |
CFR Regulation Number | 888.3530 [🔎] |
Device Problems | |
---|---|
Inadequacy Of Device Shape And/or Size | 1 |
Break | 1 |
Insufficient Information | 1 |
Fracture | 1 |
Total Device Problems | 4 |