Device Classification Name |
shoulder prosthesis, reverse configuration
|
510(k) Number |
K170748 |
Device Name |
GLOBAL UNITE Platform Shoulder System |
Applicant |
DePuy Ireland UC |
Loughbeg |
Ringaskiddy,
IE
|
|
Applicant Contact |
Carol Sandberg Ming |
Correspondent |
DePuy Orthopaedics, Inc. |
700 Orthopaedic Dr. |
Warsaw,
IN
46582
|
|
Correspondent Contact |
Kellie Myers |
Regulation Number | 888.3660
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/10/2017 |
Decision Date | 01/11/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|