Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
|
510(k) Number |
K070554 |
Device Name |
DEPUY CORAIL AMT DYSPLASIA HIP PROSTHESIS |
Applicant |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DR. |
P.O BOX 988 |
WARSAW,
IN
46581 -0988
|
|
Applicant Contact |
KATHY HARRIS |
Correspondent |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DR. |
P.O BOX 988 |
WARSAW,
IN
46581 -0988
|
|
Correspondent Contact |
KATHY HARRIS |
Regulation Number | 888.3353
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/27/2007 |
Decision Date | 09/11/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|