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 -0988
|
|
Applicant Contact |
KENNETH G ROBERTS |
Correspondent |
DEPUY, INC. |
P.O. BOX 988 |
WARSAW,
IN
46581 -0988
|
|
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
|
Recalls |
CDRH Recalls
|
|
|