Definition: Call For Pmas To Be Filed By 12/26/96 Per 61 FR 50709 On 9/27/96
Device Type ID | 4563 |
Device Name | Prosthesis, Finger, Constrained, Metal, Uncemented |
Regulation Description | Finger Joint Metal/metal Constrained Uncemented 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 Two ¿ Hips/Wrists/Fingers (JFDB2) |
Submission Type | PMA |
CFR Regulation Number | 888.3200 [🔎] |
FDA Device Classification | Class 3 Medical Device |
Product Code | KWE |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
|
Device Type ID | 4563 |
Device | Prosthesis, Finger, Constrained, Metal, Uncemented |
Product Code | KWE |
FDA Device Classification | Class 3 Medical Device |
Regulation Description | Finger Joint Metal/metal Constrained Uncemented Prosthesis. |
CFR Regulation Number | 888.3200 [🔎] |