Device Classification Name |
Shoulder Prosthesis, Reverse Configuration
|
510(k) Number |
K101996 |
Device Name |
DEPUY GLOBAL UNITE SHOULDER SYSTEM |
Applicant |
DEPUY (IRELAND) |
LOUGHBEG RINGASKIDDY |
CO. CORK,
IE
|
|
Applicant Contact |
RHONDA MYER |
Correspondent |
DEPUY (IRELAND) |
LOUGHBEG RINGASKIDDY |
CO. CORK,
IE
|
|
Correspondent Contact |
RHONDA MYER |
Regulation Number | 888.3660
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/15/2010 |
Decision Date | 12/15/2010 |
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
|
|
|