Device Classification Name |
Shoulder Prosthesis, Reverse Configuration
|
510(k) Number |
K192448 |
Device Name |
Delta Xtend Revers Shoulder System |
Applicant |
DePuy(Ireland) |
Loughbeg Ringaskiddy |
Co.Cork Munster,
IE
|
|
Applicant Contact |
Ashley Goncalo |
Correspondent |
DePuy Orthopaedies, Inc. |
700 Orthopaedies Dr. |
Warsaw,
IN
46582
|
|
Correspondent Contact |
Ashley Goncalo |
Regulation Number | 888.3660
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/06/2019 |
Decision Date | 10/04/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|