FDA.reportPublic FDA data

TORNIER S.A.S

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30083882763008388276TORNIER S.A.S1N2026-01-01176 RUE LAVOISIER Montbonnot Saint-Martin Isere FR 38330
30083882763008388276TORNIER S.A.S1N2020-04-25176 RUE LAVOISIER Montbonnot Saint-Martin Isere FR 38330

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2922871713007035K232265BLUEPRINT™ Patient Specific InstrumentationPHX2024-02-21
2922871854973689K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific InstrumentationPHX2021-11-12
1169231047386779K190521Aequalis Ascend Flex Shoulder SystemKWS2019-06-12
2922871253003347K190521Aequalis Ascend Flex Shoulder SystemKWS2019-06-12
1169231291504827K162800BLUEPRINT Patient Specific InstrumentationKWS2017-02-22
2922871581867396K162800BLUEPRINT Patient Specific InstrumentationKWS2017-02-22
1169231043597710K160555BLUEPRINT Patient Specific InstrumentationKWS2016-06-10
2922871180393385K160555BLUEPRINT Patient Specific InstrumentationKWS2016-06-10
1169231272424469K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisKWS2015-09-24
2922871696456786K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisKWS2015-09-24
2922871473542730K140478AEQUALIS REVERSED SHOULDER PROSTHESISPHX2014-08-06
1169231524044484K140478AEQUALIS REVERSED SHOULDER PROSTHESISPHX2014-08-06
1169231030566020K140082AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEMPHX2014-07-18
2922871734719630K140082AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEMPHX2014-07-18
1169231041236334K132285AEQUALIS REVERSED SHOULDER PROSTHESISPHX2013-12-05
2922871108402969K132285AEQUALIS REVERSED SHOULDER PROSTHESISPHX2013-12-05
2922871615666766K122698AEQUALIS ASCEND FLEX SHOULDER SYSTEMKWS2013-01-08
1169232036149715K122698AEQUALIS ASCEND FLEX SHOULDER SYSTEMKWS2013-01-08
2922871020390595K111902AEQUALIS SHOULDER SYSTEMKWS2011-11-03
1169231807882406K111902AEQUALIS SHOULDER SYSTEMKWS2011-11-03
1169231251398265K081059AEQUALIS REVERSED SHOULDER PROSTHESISPHX2008-07-17
2922871450090262K081059AEQUALIS REVERSED SHOULDER PROSTHESISPHX2008-07-17
2922871261836076K050316AEQUALIS REVERSED SHOULDER PROSTHESISPHX2005-03-16
1169231619753364K050316AEQUALIS REVERSED SHOULDER PROSTHESISPHX2005-03-16
2922871200392552K030941AEQUALIS REVERSED SHOULDER PROSTHESISPHX2004-05-14
1169231971342802K030941AEQUALIS REVERSED SHOULDER PROSTHESISPHX2004-05-14
2922871611975443DEN220012Tornier Pyrocarbon Humeral HeadQKW2022-12-16
2922871304884165

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PHX142024-02-21
KWS122019-06-12
QKW12022-12-16