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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