FDA.report

TORNIER

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
16493903000718467TORNIER, INC.1Y2026-01-0110801 Nesbitt Avenue South Bloomington MN US 55437
30009310343000931034Tornier S.A.S.1N2026-01-01161 rue Lavoisier Montbonnot Saint-Martin Isere FR 38330
30039023873003902387TORNIER, SAS1N2026-01-01PARC POLYTEC 20 RUE DES BERGES GRENOBLE CEDEX 1 Isere FR 38024
30049832103004983210TORNIER Inc.1N2026-01-014375 E. Park 30 Drive Columbia City IN US 46725
16493903000718467TORNIER, INC.1Y2020-04-2510801 Nesbitt Avenue South Bloomington MN US 55437
30009310343000931034Tornier S.A.S.1N2020-04-25161 rue Lavoisier Montbonnot Saint-Martin Isere FR 38330
30039023873003902387TORNIER, SAS1N2020-04-25PARC POLYTEC 20 RUE DES BERGES GRENOBLE CEDEX 1 Isere FR 38024
30049832103004983210TORNIER Inc.1N2020-04-254375 E. Park 30 Drive Columbia City IN US 46725
30083882763008388276TORNIER S.A.S1N2020-04-25176 RUE LAVOISIER Montbonnot Saint-Martin Isere FR 38330

GUDID Contact Samples

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDIDProductPhoneEmail
03700386915260AEQUALIS - DWB151+330476613500order@tornier.com
03700386916144AEQUALIS REVERSED - DWB935+330476613500order@tornier.com
03700386916151AEQUALIS REVERSED - DWB936+330476613500order@tornier.com

Registered Device Listings

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
2922331762161559K990804STAYFUSEHWC1999-04-29
2922911762161559K990804STAYFUSEHWC1999-04-29
753201832114612K990804STAYFUSEHWC1999-04-29
2922981275820981K980244AEQUALIS SHOULDER PROSTHESISKWS1999-08-23
957361594538026K980244AEQUALIS SHOULDER PROSTHESISKWS1999-08-23
2922331065765862K973453TORNIER CEMENT RESTRICTORJDI1997-12-09
2922981065765862K973453TORNIER CEMENT RESTRICTORJDI1997-12-09
753171251954432K973453TORNIER 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
2922331640230755K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)PHX2026-01-08
2922981640230755K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)PHX2026-01-08
2922331973805867K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)KWT2025-10-30
2922911973805867K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)KWT2025-10-30
2922331579063311K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)KWS2024-12-06
2922911579063311K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)KWS2024-12-06
2922331713007035K232265BLUEPRINT™ Patient Specific InstrumentationPHX2024-02-21
2922911713007035K232265BLUEPRINT™ Patient Specific InstrumentationPHX2024-02-21
2922981713007035K232265BLUEPRINT™ Patient Specific InstrumentationPHX2024-02-21
2922331394452460K230352Tornier Humeral Nail and Tornier Long Humeral NailHSB2023-10-31
2922911394452460K230352Tornier Humeral Nail and Tornier Long Humeral NailHSB2023-10-31
2922331577976792K220914Tornier Perform Humeral System – FracturePHX2022-10-14
2922911577976792K220914Tornier Perform Humeral System – FracturePHX2022-10-14
2922911372096470K220418Tornier Perform Humeral System – StemlessPKC2022-09-14
2922331372096470K220418Tornier Perform Humeral System – StemlessPKC2022-09-14
2922911194616089K213124Tomier Perform™ Reversed Glenoid Cannulated GlenospheresPHX2021-10-26
2922331194616089K213124Tomier Perform™ Reversed Glenoid Cannulated GlenospheresPHX2021-10-26
2922981854973689K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific InstrumentationPHX2021-11-12
2922911854973689K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific InstrumentationPHX2021-11-12
2922331854973689K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific InstrumentationPHX2021-11-12
2922331981062186K201315PERFORM Humeral System – StemPAO2020-09-11
2922911981062186K201315PERFORM Humeral System – StemPAO2020-09-11
2922911605502150K193247LATITUDE EV™ Total Elbow ArthroplastyJDB2020-08-05
2922331605502150K193247LATITUDE EV™ Total Elbow ArthroplastyJDB2020-08-05
753171306985370K191711ORTHOLOC™ SPS Shoulder Plating SystemHRS2019-07-17
753201306985370K191711ORTHOLOC™ SPS Shoulder Plating SystemHRS2019-07-17
2922331862353959K191711ORTHOLOC™ SPS Shoulder Plating SystemHRS2019-07-17
2922911862353959K191711ORTHOLOC™ SPS Shoulder Plating SystemHRS2019-07-17
2922911715359252K191318AEQUALIS FLEX REVIVE Shoulder SystemKWS2019-06-14
2922331715359252K191318AEQUALIS FLEX REVIVE Shoulder SystemKWS2019-06-14
753201859170008K191318AEQUALIS FLEX REVIVE Shoulder SystemKWS2019-06-14
753171859170008K191318AEQUALIS FLEX REVIVE Shoulder SystemKWS2019-06-14
957361047386779K190521Aequalis Ascend Flex Shoulder SystemKWS2019-06-12
1169231047386779K190521Aequalis Ascend Flex Shoulder SystemKWS2019-06-12
2922981253003347K190521Aequalis Ascend Flex Shoulder SystemKWS2019-06-12
2922331436574305K183696Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed GlenoidPHX2019-01-30
2922911436574305K183696Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed GlenoidPHX2019-01-30
753171925978695K183696Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed GlenoidPHX2019-01-30
753201925978695K183696Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed GlenoidPHX2019-01-30
957361925978695K183696Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed GlenoidPHX2019-01-30
2922331391668790K182461LATITUDE EV Total Elbow ArthroplastyJDB2018-12-27
2922911391668790K182461LATITUDE EV Total Elbow ArthroplastyJDB2018-12-27
753171925049336K182461LATITUDE EV Total Elbow ArthroplastyJDB2018-12-27
753201925049336K182461LATITUDE EV Total Elbow ArthroplastyJDB2018-12-27
753171617414011K181587ORTHOLOC SPS Shoulder Plating SystemHRS2018-10-05
753201617414011K181587ORTHOLOC SPS Shoulder Plating SystemHRS2018-10-05
2922331897185069K181587ORTHOLOC SPS Shoulder Plating SystemHRS2018-10-05
2922911897185069K181587ORTHOLOC SPS Shoulder Plating SystemHRS2018-10-05
753171412851223K181420Aequalis Flex Revive Shoulder SystemKWS2018-09-20
753201412851223K181420Aequalis Flex Revive Shoulder SystemKWS2018-09-20
2922331991727029K181420Aequalis Flex Revive Shoulder SystemKWS2018-09-20
2922911991727029K181420Aequalis Flex Revive Shoulder SystemKWS2018-09-20
753171299436159K171010Latitude EV Total Elbow ArthroplastyJDB2017-08-31
753201299436159K171010Latitude EV Total Elbow ArthroplastyJDB2017-08-31
957361299436159K171010Latitude EV Total Elbow ArthroplastyJDB2017-08-31
2922331402134835K171010Latitude EV Total Elbow ArthroplastyJDB2017-08-31
2922911402134835K171010Latitude EV Total Elbow ArthroplastyJDB2017-08-31
957361291504827K162800BLUEPRINT Patient Specific InstrumentationKWS2017-02-22
1169231291504827K162800BLUEPRINT Patient Specific InstrumentationKWS2017-02-22
2922981581867396K162800BLUEPRINT Patient Specific InstrumentationKWS2017-02-22
957361423182976K161789BLUEPRINT Patient Specific InstrumentationKWS2016-12-27
2922981931519231K161789BLUEPRINT Patient Specific InstrumentationKWS2016-12-27
753171181720471K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidPHX2016-11-15
753201181720471K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidPHX2016-11-15
957361181720471K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidPHX2016-11-15
2922331740312837K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidPHX2016-11-15
2922911740312837K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidPHX2016-11-15
2922981740312837K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidPHX2016-11-15
2922331023280719K160975Aequalis PerFORM+ Shoulder SystemKWS2016-06-10
2922911023280719K160975Aequalis PerFORM+ Shoulder SystemKWS2016-06-10
753201473021302K160975Aequalis PerFORM+ Shoulder SystemKWS2016-06-10
753171473021302K160975Aequalis PerFORM+ Shoulder SystemKWS2016-06-10
1169231043597710K160555BLUEPRINT Patient Specific InstrumentationKWS2016-06-10
957361043597710K160555BLUEPRINT Patient Specific InstrumentationKWS2016-06-10
2922981180393385K160555BLUEPRINT Patient Specific InstrumentationKWS2016-06-10
1169231272424469K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisKWS2015-09-24
957361272424469K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisKWS2015-09-24
2922981696456786K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisKWS2015-09-24
753201318527911K150871ForeFoot STP SystemHWC2015-08-04
753171318527911K150871ForeFoot STP SystemHWC2015-08-04
2922331615378999K150583Aequalis PerFORM+ Shoulder SystemKWS2015-04-23
2922911615378999K150583Aequalis PerFORM+ Shoulder SystemKWS2015-04-23
753172066960752K150583Aequalis PerFORM+ Shoulder SystemKWS2015-04-23
753202066960752K150583Aequalis PerFORM+ Shoulder SystemKWS2015-04-23
2922331247702283K143552Simpliciti Shoulder SystemPKC2015-03-04
2922911247702283K143552Simpliciti Shoulder SystemPKC2015-03-04
2922981247702283K143552Simpliciti Shoulder SystemPKC2015-03-04
753171824752099K143552Simpliciti Shoulder SystemPKC2015-03-04
753201824752099K143552Simpliciti Shoulder SystemPKC2015-03-04
957361824752099K143552Simpliciti Shoulder SystemPKC2015-03-04
2922981035926974K143374BLUEPRINT Patient Specific InstrumentationKWS2015-04-08
957361090458764K143374BLUEPRINT Patient Specific InstrumentationKWS2015-04-08
753201961166158K142148ORTHOHELIX STAPLE SYSTEMJDR2014-08-21
753171961166158K142148ORTHOHELIX STAPLE SYSTEMJDR2014-08-21
2922911965103578K142148ORTHOHELIX STAPLE SYSTEMJDR2014-08-21
2922331965103578K142148ORTHOHELIX STAPLE SYSTEMJDR2014-08-21
753171372926929K141301MAXLOCK EXTREME ELBOW FRACTURE SYSTEMHRS2014-07-11
753201372926929K141301MAXLOCK EXTREME ELBOW FRACTURE SYSTEMHRS2014-07-11
2922911764921269K141301MAXLOCK EXTREME ELBOW FRACTURE SYSTEMHRS2014-07-11
2922331764921269K141301MAXLOCK EXTREME ELBOW FRACTURE SYSTEMHRS2014-07-11
753171643854493K141029TORNIER AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEMPHX2014-06-18
753201643854493K141029TORNIER AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEMPHX2014-06-18
2922331871837364K141029TORNIER AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEMPHX2014-06-18

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
HRS772019-07-17
KWS652024-12-06
PHX602026-01-08
JDB262020-08-05
HWC242015-08-04
MBI162014-04-04
HSB102023-10-31
PKC82022-09-14
JDR82014-08-21
HTY82014-08-21
KYI72006-05-10
MAI62013-05-13
JDI62000-07-20
HTN42014-01-03
HSD42008-02-19
JDW42007-11-08
KTT42006-12-22
KWT32025-10-30
FTL32012-01-25
JWH32011-05-05
QKW22022-12-16
PAO22020-09-11
NWJ22013-04-04
HSX22012-07-25
LZN22006-09-14
LXT22005-10-27
KWI22000-08-31
KRR12012-02-23

PMN

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GUDID

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