| Device Classification Name |
Prosthesis, Hip, Hemi-, Femoral, Metal Ball
|
| 510(k) Number |
K903084 |
| Device Name |
MODULAR CATHCART FRACTURE SYSTEM |
| Applicant |
| Depuy, Inc. |
| P.O. Box 988 |
|
Warsaw,
IN
46581
|
|
| Applicant Contact |
KENNETH G ROBERTS |
| Correspondent |
| Depuy, Inc. |
| P.O. Box 988 |
|
Warsaw,
IN
46581
|
|
| Correspondent Contact |
KENNETH G ROBERTS |
| Regulation Number | 888.3360 |
| Classification Product Code |
|
| Date Received | 07/12/1990 |
| Decision Date | 10/03/1990 |
| 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
|
| Recalls |
CDRH Recalls
|
|
|