FDA.reportPublic FDA data

Tornier S.A.S.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30009310343000931034Tornier S.A.S.1N2026-01-01161 rue Lavoisier Montbonnot Saint-Martin Isere FR 38330
30009310343000931034Tornier S.A.S.1N2020-04-25161 rue Lavoisier Montbonnot Saint-Martin Isere FR 38330

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
957361061226856K994393AEQUALIS UNIVERSAL SHOULDER GLENOIDKWS2000-06-22
2922981815012218K994393AEQUALIS UNIVERSAL SHOULDER GLENOIDKWS2000-06-22
957361469190510K994392AEQUALIS SHOULDER FRACTURE SYSTEMKWS2000-03-10
2922982025940209K994392AEQUALIS SHOULDER FRACTURE SYSTEMKWS2000-03-10
2922981452710078K994041TORNIER BIPOLAR RADIAL HEAD PROSTHESISKWI2000-08-31
957361897338838K994041TORNIER BIPOLAR RADIAL HEAD PROSTHESISKWI2000-08-31
2922981275820981K980244AEQUALIS SHOULDER PROSTHESISKWS1999-08-23
957361594538026K980244AEQUALIS SHOULDER PROSTHESISKWS1999-08-23
2922981065765862K973453TORNIER CEMENT RESTRICTORJDI1997-12-09
957361251954432K973453TORNIER CEMENT RESTRICTORJDI1997-12-09
957361033114467K952928AEQUALIS SHOULDER SYSTEM FOR TOTAL & HEMISHOULDER APPLICATIONSKWS1995-09-27
2922981381099311K952928AEQUALIS SHOULDER SYSTEM FOR TOTAL & HEMISHOULDER APPLICATIONSKWS1995-09-27
2922981493146220K253674Blueprint Patient-Specific InstrumentationPHX2026-04-03
2922981640230755K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)PHX2026-01-08
2922981860090559K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidPHX2024-10-10
2922981713007035K232265BLUEPRINT™ Patient Specific InstrumentationPHX2024-02-21
2922981854973689K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific InstrumentationPHX2021-11-12
957361047386779K190521Aequalis Ascend Flex Shoulder SystemKWS2019-06-12
2922981253003347K190521Aequalis Ascend Flex Shoulder SystemKWS2019-06-12
957361925978695K183696Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed GlenoidPHX2019-01-30
957361299436159K171010Latitude EV Total Elbow ArthroplastyJDB2017-08-31
957361291504827K162800BLUEPRINT Patient Specific InstrumentationKWS2017-02-22
2922981581867396K162800BLUEPRINT Patient Specific InstrumentationKWS2017-02-22
957361423182976K161789BLUEPRINT Patient Specific InstrumentationKWS2016-12-27
2922981931519231K161789BLUEPRINT Patient Specific InstrumentationKWS2016-12-27
957361181720471K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidPHX2016-11-15
2922981740312837K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidPHX2016-11-15
957361043597710K160555BLUEPRINT Patient Specific InstrumentationKWS2016-06-10
2922981180393385K160555BLUEPRINT Patient Specific InstrumentationKWS2016-06-10
957361272424469K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisKWS2015-09-24
2922981696456786K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisKWS2015-09-24
2922981247702283K143552Simpliciti Shoulder SystemPKC2015-03-04
957361824752099K143552Simpliciti Shoulder SystemPKC2015-03-04
2922981035926974K143374BLUEPRINT Patient Specific InstrumentationKWS2015-04-08
957361090458764K143374BLUEPRINT Patient Specific InstrumentationKWS2015-04-08
2922981473542730K140478AEQUALIS REVERSED SHOULDER PROSTHESISPHX2014-08-06
957361524044484K140478AEQUALIS REVERSED SHOULDER PROSTHESISPHX2014-08-06
957361030566020K140082AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEMPHX2014-07-18
2922981734719630K140082AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEMPHX2014-07-18
957361041236334K132285AEQUALIS REVERSED SHOULDER PROSTHESISPHX2013-12-05
2922981108402969K132285AEQUALIS REVERSED SHOULDER PROSTHESISPHX2013-12-05
957361106949377K131231AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROTHESISPHX2013-10-16
2922981264632267K131231AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROTHESISPHX2013-10-16
957361878896491K130051611 ANKLE FUSION NAILHSB2013-07-15
2922981615666766K122698AEQUALIS ASCEND FLEX SHOULDER SYSTEMKWS2013-01-08
957362036149715K122698AEQUALIS ASCEND FLEX SHOULDER SYSTEMKWS2013-01-08
957361583013205K120262HLS UNI EVOLUTION & U-KNEETECHSX2012-07-25
957361272527681K112144AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESISPHX2012-03-13
2922981831886419K112144AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESISPHX2012-03-13
957361836010066K111970KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENTKRR2012-02-23
2922981020390595K111902AEQUALIS SHOULDER SYSTEMKWS2011-11-03
957361807882406K111902AEQUALIS SHOULDER SYSTEMKWS2011-11-03
957361567108030K100562LATITUDE ELBOW PROSTHESISJDB2010-06-29
957361865448795K100562LATITUDE ELBOW PROSTHESISJDB2010-06-29
957361358955597K100142AEQUALIS REVERSED SHOULDER PROSTHESISPHX2010-05-06
2922981506870060K100142AEQUALIS REVERSED SHOULDER PROSTHESISPHX2010-05-06
957361301979092K094013HLS KNEETEC SYSTEMJWH2011-05-05
957361694592380K082120AEQUALIS REVERSED FRACTURE SHOULDER PROTHESISKWS2008-10-24
2922981853771301K082120AEQUALIS REVERSED FRACTURE SHOULDER PROTHESISKWS2008-10-24
957361251398265K081059AEQUALIS REVERSED SHOULDER PROSTHESISPHX2008-07-17
2922981450090262K081059AEQUALIS REVERSED SHOULDER PROSTHESISPHX2008-07-17
957361024356304K071948AEQUALIS REVERSED ADAPTERPHX2007-10-18
2922981697209938K071948AEQUALIS REVERSED ADAPTERPHX2007-10-18
957361863958148K063551AEQUALIS HUMERAL PLATEKTT2006-12-22
957361220435056K063081AEQUALIS SHOULDER SYSTEMHSD2006-11-09
957361498986169K061824TORNIER CEMENT RESTRICTORLZN2006-09-14
2922981654360205K061824TORNIER CEMENT RESTRICTORLZN2006-09-14
2922981653768571K061439AEQUALIS REVERSED PROSTHESISPHX2006-07-20
957361918370485K061439AEQUALIS REVERSED PROSTHESISPHX2006-07-20
957361204139167K060545UNITY HUMERAL PLATEKTT2006-04-21
2922981748885292K060438RHSJDB2006-04-18
957361954913600K060438RHSJDB2006-04-18
957361342575704K060386NEXA CARPO METACARPAL IMPLANTKYI2006-05-10
2922981996398655K060386NEXA CARPO METACARPAL IMPLANTKYI2006-05-10
957361099192372K060209AEQUALIS SHOULDER FRACTURE SYSTEM & AEQUALIS SHOULDER SYSTEMKWS2006-03-02
2922981460999586K060209AEQUALIS SHOULDER FRACTURE SYSTEM & AEQUALIS SHOULDER SYSTEMKWS2006-03-02
957361350135111K050848TORNIER ELBOW PROSTHESISJDB2005-07-14
2922981261836076K050316AEQUALIS REVERSED SHOULDER PROSTHESISPHX2005-03-16
957361619753364K050316AEQUALIS REVERSED SHOULDER PROSTHESISPHX2005-03-16
957361852723652K043077MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM; AEQUALIS SHOULDER SYSTEMKWS2004-12-17
2922981393537684K041873AEQUALIS REVERSED SHOULDER PROSTHESISPHX2004-08-25
957361963939805K041873AEQUALIS REVERSED SHOULDER PROSTHESISPHX2004-08-25
957361624799770K041339AEQUALIS SHOULDER SYSTEMKWS2004-06-17
2922981770790956K041339AEQUALIS SHOULDER SYSTEMKWS2004-06-17
957361581574406K032079HLS NOETOS SYSTEMJWH2003-10-02
2922981200392552K030941AEQUALIS REVERSED SHOULDER PROSTHESISPHX2004-05-14
957361971342802K030941AEQUALIS REVERSED SHOULDER PROSTHESISPHX2004-05-14
957361850521093K022211HLS UNI EVOLUTION PROSTHESISHSX2003-05-22
957361607004736K013906HLS NOETOS SYSTEMJWH2002-07-17
957361065900374K012212MODIFICATION TO AEQUALIS SHOULDER SYSTEMKWS2001-08-15
2922981819412059K012212MODIFICATION TO AEQUALIS SHOULDER SYSTEMKWS2001-08-15
2922981020492194K011942AEQUALIS PRESS-FIT SHOULDER PROSTHESISHSD2001-07-13
957361186730113K011942AEQUALIS PRESS-FIT SHOULDER PROSTHESISHSD2001-07-13
2922981118833509K001932TORNIER CEMENT RESTRICTORJDI2000-07-20
957361755423925K001932TORNIER CEMENT RESTRICTORJDI2000-07-20
2922981611975443DEN220012Tornier Pyrocarbon Humeral HeadQKW2022-12-16
957361003245505
957361005551989
957361051230813
957361084113702
957361114247456
957361173245097
957361173684473
957361194802339
957361201449710
957361208056755
957361229687187
957361243462310
957361244638591
957361316180946
957361317092381
957361320257634
957361321083423
957361403383911
957361419170236
957361424348168
957361425874043
957361431528340
957361516511804
957361519499792

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KWS332019-06-12
PHX322026-04-03
JDB62017-08-31
JDI42000-07-20
JWH32011-05-05
HSD32006-11-09
PKC22015-03-04
HSX22012-07-25
KTT22006-12-22
LZN22006-09-14
KYI22006-05-10
KWI22000-08-31
QKW12022-12-16
HSB12013-07-15
KRR12012-02-23

PMN#