Device Classification Name |
Shoulder Prosthesis, Reverse Configuration
|
510(k) Number |
K183077 |
Device Name |
Delta Xtend Reverse Shoulder System |
Applicant |
DePuy (Ireland) |
Loughbeg Ringaskiddy |
Co. Cork Munster,
IE
|
|
Applicant Contact |
Yayoi Fujimaki |
Correspondent |
Depuy Orthopajedics, Inc. |
700 Orthopaedic Dr. |
Warsaw,
IN
46582
|
|
Correspondent Contact |
Yayoi Fujimaki |
Regulation Number | 888.3660
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/05/2018 |
Decision Date | 05/17/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|