Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
|
510(k) Number |
K192919 |
Device Name |
Pinnacle Duofix HA Acetabular Cup Prosthesis |
Applicant |
DePuy Orthopaedics, Inc. |
700 Orthopaedic Dr. |
Warsaw,
IN
46582
|
|
Applicant Contact |
Kathy Harris |
Correspondent |
DePuy (Ireland) |
Loughbeg, Ringakiddy |
Cork,
IE
P43D82
|
|
Correspondent Contact |
Margaret Shaughnessy |
Regulation Number | 888.3358
|
Classification Product Code |
|
Date Received | 10/15/2019 |
Decision Date | 11/26/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|