Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
|
510(k) Number |
K173960 |
Device Name |
DePuy Corail AMT Hip Prosthesis |
Applicant |
DePuy France S.A.S. |
7 Allee Irene Joliot Curie Bp256 |
Saint Priest Cedex Rhone-Alpes,
FR
69801
|
|
Applicant Contact |
David Holzwarth |
Correspondent |
DePuy Orthopaedics, Inc. |
700 Orthopaedic Dr. |
Warsaw,
IN
46582
|
|
Correspondent Contact |
Melissa Cook |
Regulation Number | 888.3353
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/28/2017 |
Decision Date | 09/21/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|