| Device Classification Name |
Prosthesis, Wrist, Semi-Constrained
|
| 510(k) Number |
K790774 |
| Device Name |
LODA WRIST PROSTHESIS |
| Applicant |
| Depuy, Inc. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Correspondent |
| Depuy, Inc. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Regulation Number | 888.3800 |
| Classification Product Code |
|
| Date Received | 04/20/1979 |
| Decision Date | 08/03/1979 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Orthopedic
|
| 510k Review Panel |
Orthopedic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|