Device Type ID | 4572 |
Device Name | Prosthesis, Wrist, Carpal Lunate |
Regulation Description | Wrist Joint Carpal Lunate 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 | 888.3750 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | KWN |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
|
Device Type ID | 4572 |
Device | Prosthesis, Wrist, Carpal Lunate |
Product Code | KWN |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Wrist Joint Carpal Lunate Polymer Prosthesis. |
CFR Regulation Number | 888.3750 [🔎] |
Premarket Reviews | ||
---|---|---|
Manufacturer | Decision | |
ARTHROCARE CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ARTHROSURFACE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 |
Device Problems | |
---|---|
Insufficient Information | 2 |
Migration Or Expulsion Of Device | 2 |
Inadequacy Of Device Shape And/or Size | 1 |
Total Device Problems | 5 |