Device Classification Name |
prosthesis, shoulder, semi-constrained, metal/polymer cemented
|
510(k) Number |
K122698 |
Device Name |
AEQUALIS ASCEND FLEX SHOULDER SYSTEM |
Applicant |
Tornier SAS |
10801 Nesbitt Avenue South |
Bloomington,
MN
55437
|
|
Applicant Contact |
BRAHIM HADRI |
Correspondent |
Tornier SAS |
10801 Nesbitt Avenue South |
Bloomington,
MN
55437
|
|
Correspondent Contact |
BRAHIM HADRI |
Regulation Number | 888.3660
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/04/2012 |
Decision Date | 01/08/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|