Device Type ID | 4573 |
Device Name | Prosthesis, Wrist, Carpal Scaphoid |
Regulation Description | Wrist Joint Carpal Scaphoid Polymer 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 | 510(k) |
CFR Regulation Number | 888.3760 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | KWO |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
|
Device Type ID | 4573 |
Device | Prosthesis, Wrist, Carpal Scaphoid |
Product Code | KWO |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Wrist Joint Carpal Scaphoid Polymer Prosthesis. |
CFR Regulation Number | 888.3760 [🔎] |
Device Problems | |
---|---|
Unintended Movement | 1 |
Migration Or Expulsion Of Device | 1 |
Total Device Problems | 2 |