Device Classification Name |
prosthesis, hip, semi-constrained (metal uncemented acetabular component)
|
510(k) Number |
K850055 |
Device Name |
PROFILE FEMORAL HIP |
Applicant |
DEPUY, INC. |
P.O. BOX 988 |
WARSAW,
IN
46581 -0988
|
|
Applicant Contact |
STEPHEN M DOYLE |
Correspondent |
DEPUY, INC. |
P.O. BOX 988 |
WARSAW,
IN
46581 -0988
|
|
Correspondent Contact |
STEPHEN M DOYLE |
Regulation Number | 888.3330
|
Classification Product Code |
|
Date Received | 01/08/1985 |
Decision Date | 04/23/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|