Device Classification Name |
prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
|
510(k) Number |
K192946 |
Device Name |
DePuy Corail AMT Hip Prosthesis |
Applicant |
DePuy Orthopaedics, Inc. |
700 Orthopaedic Drive |
Warsaw,
IN
46582
|
|
Applicant Contact |
Kathy Harris |
Correspondent |
DePuy (Ireland) |
Loughbeg, Ringaskiddy |
Cork,
IE
P43ED82
|
|
Correspondent Contact |
Susan Mullane |
Regulation Number | 888.3353
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/18/2019 |
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
|
|
|