FDA.reportPublic FDA data

Tornier S.A.S.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
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
957361469190510K994392AEQUALIS SHOULDER FRACTURE SYSTEMKWS2000-03-10
957361897338838K994041TORNIER BIPOLAR RADIAL HEAD PROSTHESISKWI2000-08-31
957361594538026K980244AEQUALIS SHOULDER PROSTHESISKWS1999-08-23
957361251954432K973453TORNIER CEMENT RESTRICTORJDI1997-12-09
957361033114467K952928AEQUALIS SHOULDER SYSTEM FOR TOTAL & HEMISHOULDER APPLICATIONSKWS1995-09-27
957361047386779K190521Aequalis 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
957361423182976K161789BLUEPRINT Patient Specific InstrumentationKWS2016-12-27
957361181720471K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidPHX2016-11-15
957361043597710K160555BLUEPRINT Patient Specific InstrumentationKWS2016-06-10
957361272424469K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisKWS2015-09-24
957361824752099K143552Simpliciti Shoulder SystemPKC2015-03-04
957361090458764K143374BLUEPRINT Patient Specific InstrumentationKWS2015-04-08
957361524044484K140478AEQUALIS REVERSED SHOULDER PROSTHESISPHX2014-08-06
957361030566020K140082AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEMPHX2014-07-18
957361041236334K132285AEQUALIS REVERSED SHOULDER PROSTHESISPHX2013-12-05
957361106949377K131231AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROTHESISPHX2013-10-16
957361878896491K130051611 ANKLE FUSION NAILHSB2013-07-15
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
957361836010066K111970KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENTKRR2012-02-23
957361807882406K111902AEQUALIS SHOULDER SYSTEMKWS2011-11-03
957361567108030K100562LATITUDE ELBOW PROSTHESISJDB2010-06-29
957361865448795K100562LATITUDE ELBOW PROSTHESISJDB2010-06-29
957361358955597K100142AEQUALIS REVERSED SHOULDER PROSTHESISPHX2010-05-06
957361301979092K094013HLS KNEETEC SYSTEMJWH2011-05-05
957361694592380K082120AEQUALIS REVERSED FRACTURE SHOULDER PROTHESISKWS2008-10-24
957361251398265K081059AEQUALIS REVERSED SHOULDER PROSTHESISPHX2008-07-17
957361024356304K071948AEQUALIS REVERSED ADAPTERPHX2007-10-18
957361863958148K063551AEQUALIS HUMERAL PLATEKTT2006-12-22
957361220435056K063081AEQUALIS SHOULDER SYSTEMHSD2006-11-09
957361498986169K061824TORNIER CEMENT RESTRICTORLZN2006-09-14
957361918370485K061439AEQUALIS REVERSED PROSTHESISPHX2006-07-20
957361204139167K060545UNITY HUMERAL PLATEKTT2006-04-21
957361954913600K060438RHSJDB2006-04-18
957361342575704K060386NEXA CARPO METACARPAL IMPLANTKYI2006-05-10
957361099192372K060209AEQUALIS SHOULDER FRACTURE SYSTEM & AEQUALIS SHOULDER SYSTEMKWS2006-03-02
957361350135111K050848TORNIER ELBOW PROSTHESISJDB2005-07-14
957361619753364K050316AEQUALIS REVERSED SHOULDER PROSTHESISPHX2005-03-16
957361852723652K043077MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM; AEQUALIS SHOULDER SYSTEMKWS2004-12-17
957361963939805K041873AEQUALIS REVERSED SHOULDER PROSTHESISPHX2004-08-25
957361624799770K041339AEQUALIS SHOULDER SYSTEMKWS2004-06-17
957361581574406K032079HLS NOETOS SYSTEMJWH2003-10-02
957361971342802K030941AEQUALIS REVERSED SHOULDER PROSTHESISPHX2004-05-14
957361850521093K022211HLS UNI EVOLUTION PROSTHESISHSX2003-05-22
957361607004736K013906HLS NOETOS SYSTEMJWH2002-07-17
957361065900374K012212MODIFICATION TO AEQUALIS SHOULDER SYSTEMKWS2001-08-15
957361186730113K011942AEQUALIS PRESS-FIT SHOULDER PROSTHESISHSD2001-07-13
957361755423925K001932TORNIER CEMENT RESTRICTORJDI2000-07-20
957361003245505
957361005551989
957361051230813
957361084113702
957361114247456
957361173245097
957361173684473
957361194802339
957361201449710
957361208056755
957361229687187
957361243462310
957361244638591
957361316180946
957361317092381
957361320257634
957361321083423
957361403383911
957361419170236
957361424348168
957361425874043
957361431528340
957361516511804
957361519499792
957361541418848
957361555454987
957361576010538
957361587914684
957361602016288
957361629566681
957361635469512
957361722931157
957361774143631
957361780607745
957361815462492
957361849781204
957361855997435
957361925298051
957361994781748
957362073587046

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KWS172019-06-12
PHX142019-01-30
JDB52017-08-31
JWH32011-05-05
HSX22012-07-25
KTT22006-12-22
HSD22006-11-09
JDI22000-07-20
PKC12015-03-04
HSB12013-07-15
KRR12012-02-23
LZN12006-09-14
KYI12006-05-10
KWI12000-08-31

PMN#