Device Classification Name |
shoulder prosthesis, reverse configuration
|
510(k) Number |
K173717 |
Device Name |
Integra TITAN Reverse Shoulder System |
Applicant |
Integra LifeSciences Corporation |
8700 Cameron Road |
Suite 100 |
Austin,
TX
78754
|
|
Applicant Contact |
Kathleen McGuire |
Correspondent |
Integra LifeSciences Corporation |
8700 Cameron Road |
Suite 100 |
Austin,
TX
78754
|
|
Correspondent Contact |
Blesson Abraham |
Regulation Number | 888.3660
|
Classification Product Code |
|
Date Received | 12/05/2017 |
Decision Date | 06/21/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|