Device Classification Name |
shoulder prosthesis, reverse configuration
|
510(k) Number |
K131231 |
Device Name |
AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS |
Applicant |
Tornier SAS |
161 RUE LAVOISIER |
MONTBONNOT SAINT MARTIN,
FR
38330
|
|
Applicant Contact |
SEVERINE BONNETON |
Correspondent |
Tornier SAS |
161 RUE LAVOISIER |
MONTBONNOT SAINT MARTIN,
FR
38330
|
|
Correspondent Contact |
SEVERINE BONNETON |
Regulation Number | 888.3660
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/30/2013 |
Decision Date | 10/16/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|