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FDA 510(k) Applications Submitted by Tornier SAS
FDA 510(k) Number
Submission Date
Device Name
Applicant
K140082
01/13/2014
AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEM
Tornier SAS
K160555
02/29/2016
BLUEPRINT Patient Specific Instrumentation
TORNIER SAS
K161789
06/29/2016
BLUEPRINT Patient Specific Instrumentation
TORNIER SAS
K162800
10/05/2016
BLUEPRINT Patient Specific Instrumentation
TORNIER SAS
K203315
11/10/2020
BLUEPRINTÖ Patient Specific Instrumentation
Tornier SAS
K122698
09/04/2012
AEQUALIS ASCEND FLEX SHOULDER SYSTEM
Tornier SAS
K130051
01/09/2013
611 ANKLE FUSION NAIL
Tornier SAS
K152966
10/07/2015
Aequalis Fx2
Tornier SAS
K190521
03/04/2019
Aequalis Ascend Flex Shoulder System
Tornier SAS
DEN220012
02/08/2022
Tornier Pyrocarbon Humeral Head
Tornier SAS
K140478
02/26/2014
AEQUALIS REVERSED SHOULDER PROSTHESIS
Tornier SAS
K141345
05/22/2014
AEQUALIS FX2
Tornier SAS
K222510
08/19/2022
Blueprint Mixed Reality system
Tornier SAS
K130533
03/01/2013
SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS
Tornier SAS
K131231
04/30/2013
AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS
Tornier SAS
K151293
05/15/2015
Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis
Tornier SAS
K153452
11/30/2015
Salto XT, Salto Talaris
Tornier SAS
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