Device Classification Name |
shoulder prosthesis, reverse configuration
|
510(k) Number |
K112615 |
Device Name |
AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM |
Applicant |
TORNIER, INC. |
7701 FRANCE AVE SOUTH |
SUITE 600 |
EDINA,
MN
55435
|
|
Applicant Contact |
BRAHIM HADRI |
Correspondent |
TORNIER, INC. |
7701 FRANCE AVE SOUTH |
SUITE 600 |
EDINA,
MN
55435
|
|
Correspondent Contact |
BRAHIM HADRI |
Regulation Number | 888.3660
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/08/2011 |
Decision Date | 10/11/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|