FDA.reportPublic FDA data

TORNIER Inc.

Matched from indexed company URL: Tornier-Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30049832103004983210TORNIER Inc.1N2026-01-014375 E. Park 30 Drive Columbia City IN US 46725
30049832103004983210TORNIER Inc.1N2020-04-254375 E. Park 30 Drive Columbia City IN US 46725

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2922911762161559K990804STAYFUSEHWC1999-04-29
753201832114612K990804STAYFUSEHWC1999-04-29
2922911973805867K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)KWT2025-10-30
2922911579063311K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)KWS2024-12-06
2922911713007035K232265BLUEPRINT™ Patient Specific InstrumentationPHX2024-02-21
2922911394452460K230352Tornier Humeral Nail and Tornier Long Humeral NailHSB2023-10-31
2922911577976792K220914Tornier Perform Humeral System – FracturePHX2022-10-14
2922911372096470K220418Tornier Perform Humeral System – StemlessPKC2022-09-14
2922911194616089K213124Tomier Perform™ Reversed Glenoid Cannulated GlenospheresPHX2021-10-26
2922911854973689K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific InstrumentationPHX2021-11-12
2922911981062186K201315PERFORM Humeral System – StemPAO2020-09-11
2922911605502150K193247LATITUDE EV™ Total Elbow ArthroplastyJDB2020-08-05
753201306985370K191711ORTHOLOC™ SPS Shoulder Plating SystemHRS2019-07-17
2922911862353959K191711ORTHOLOC™ SPS Shoulder Plating SystemHRS2019-07-17
2922911715359252K191318AEQUALIS FLEX REVIVE Shoulder SystemKWS2019-06-14
753201859170008K191318AEQUALIS FLEX REVIVE Shoulder SystemKWS2019-06-14
2922911436574305K183696Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed GlenoidPHX2019-01-30
753201925978695K183696Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed GlenoidPHX2019-01-30
2922911391668790K182461LATITUDE EV Total Elbow ArthroplastyJDB2018-12-27
753201925049336K182461LATITUDE EV Total Elbow ArthroplastyJDB2018-12-27
753201617414011K181587ORTHOLOC SPS Shoulder Plating SystemHRS2018-10-05
2922911897185069K181587ORTHOLOC SPS Shoulder Plating SystemHRS2018-10-05
753201412851223K181420Aequalis Flex Revive Shoulder SystemKWS2018-09-20
2922911991727029K181420Aequalis Flex Revive Shoulder SystemKWS2018-09-20
753201299436159K171010Latitude EV Total Elbow ArthroplastyJDB2017-08-31
2922911402134835K171010Latitude EV Total Elbow ArthroplastyJDB2017-08-31
753201181720471K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidPHX2016-11-15
2922911740312837K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidPHX2016-11-15
2922911023280719K160975Aequalis PerFORM+ Shoulder SystemKWS2016-06-10
753201473021302K160975Aequalis PerFORM+ Shoulder SystemKWS2016-06-10
753201318527911K150871ForeFoot STP SystemHWC2015-08-04
2922911615378999K150583Aequalis PerFORM+ Shoulder SystemKWS2015-04-23
753202066960752K150583Aequalis PerFORM+ Shoulder SystemKWS2015-04-23
2922911247702283K143552Simpliciti Shoulder SystemPKC2015-03-04
753201824752099K143552Simpliciti Shoulder SystemPKC2015-03-04
753201961166158K142148ORTHOHELIX STAPLE SYSTEMJDR2014-08-21
2922911965103578K142148ORTHOHELIX STAPLE SYSTEMJDR2014-08-21
753201372926929K141301MAXLOCK EXTREME ELBOW FRACTURE SYSTEMHRS2014-07-11
2922911764921269K141301MAXLOCK EXTREME ELBOW FRACTURE SYSTEMHRS2014-07-11
753201643854493K141029TORNIER AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEMPHX2014-06-18
2922911871837364K141029TORNIER AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEMPHX2014-06-18
2922911093623032K141004INTRAOSSEOUS FIXATION SYSTEMHTY2014-08-21
753201642131543K141004INTRAOSSEOUS FIXATION SYSTEMHTY2014-08-21
2922911515537364K133777TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHORMBI2014-04-04
753201788286357K133777TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHORMBI2014-04-04
2922911576666824K133376AEQUALIS HUMERAL NAIL; SIZES 7MM & 8MM X 210, 230, 250, 270MM; LEFT AND RIGHTHSB2013-12-05
753201629094424K133376AEQUALIS HUMERAL NAIL; SIZES 7MM & 8MM X 210, 230, 250, 270MM; LEFT AND RIGHTHSB2013-12-05
2922911041628107K132733ORTHOHELIX SYNDESMOSIS FIXATION DEVICESHTN2014-01-03
753201424021403K132733ORTHOHELIX SYNDESMOSIS FIXATION DEVICESHTN2014-01-03
2922911175771023K132632TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLESMBI2013-09-19
753201998649311K132632TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLESMBI2013-09-19
2922911659206257K132591MAXLOCK EXTREME SYSTEMHRS2013-09-17
753202017982382K132591MAXLOCK EXTREME SYSTEMHRS2013-09-17
2922911181195048K131324MAXTORQUE SCREW SYSTEMHWC2013-05-31
753201637040714K131324MAXTORQUE SCREW SYSTEMHWC2013-05-31
753201036111138K130832ORTHOHELIX STAPLE SYSTEMJDR2013-08-15
2922911554488216K130832ORTHOHELIX STAPLE SYSTEMJDR2013-08-15
2922911727514404K123203MAXLOCK EXTREME SYSTEM MODEL MXLHRS2012-12-14
753201959398983K123203MAXLOCK EXTREME SYSTEM MODEL MXLHRS2012-12-14
2922911382806896K122635TORNIER INSITE FT BIOCOMPOSITE SUTURE ANCHORMAI2013-05-13
753201816101837K122635TORNIER INSITE FT BIOCOMPOSITE SUTURE ANCHORMAI2013-05-13
2922911822000947K122005MAXLOCK EXTREME SYSTEMHRS2012-09-06
753201903567343K122005MAXLOCK EXTREME SYSTEMHRS2012-09-06
753201001198069K121493ASCEND SHOULDER SYSTEMKWS2012-06-20
753201641270365K121437MINI MAXLOCK EXTREME PLATING SYSTEMHRS2012-06-13
2922911827444124K121437MINI MAXLOCK EXTREME PLATING SYSTEMHRS2012-06-13
753201006804446K120794ASCEND SHOULDER SYSTEMKWS2012-04-13
2922911638852831K120739AEQUALIS ADJUSTABLE MODULAR REVERSE SHOULDER SYSTEMPHX2012-07-05
753201669332079K120739AEQUALIS ADJUSTABLE MODULAR REVERSE SHOULDER SYSTEMPHX2012-07-05
753201233327996K120165INTRAOSSEOUS FIXATION SYSTEMHTY2012-04-17
2922911445311560K120165INTRAOSSEOUS FIXATION SYSTEMHTY2012-04-17
2922911019454992K120157MINI MAXLOCK EXTREME PLATING SYSTEMHRS2012-04-10
753201840455136K120157MINI MAXLOCK EXTREME PLATING SYSTEMHRS2012-04-10
2922911218488497K113413ASCEND SHOULDER SYSTEMKWS2012-03-09
753201304247277K113413ASCEND SHOULDER SYSTEMKWS2012-03-09
2922911316752460K113048MAXLOCK EXTREME SYSTEMHRS2012-01-30
753202023092664K113048MAXLOCK EXTREME SYSTEMHRS2012-01-30
753201195912347K111041MINI VARIABLE SYSTEMHRS2011-06-06
2922911254069184K111041MINI VARIABLE SYSTEMHRS2011-06-06
753201467665210K110773TORNIER INSITE FT SUTURE ANCHORMBI2011-06-02
2922911657756809K110773TORNIER INSITE FT SUTURE ANCHORMBI2011-06-02
753201470530247K103007AFFINITI TOTAL AND HEMI-SHOULDER SYSTEMKWS2010-11-09
753201089274433K102156MAXLOCK EXTREME EXTREMITY PLATING SYSTEM DISTAL RADIUS PLATES AND SCREWSHRS2010-09-30
2922911426815828K101962MINI MAXLOCK EXTREME PLATING SYSTEMHRS2010-09-27
753202047491767K101962MINI MAXLOCK EXTREME PLATING SYSTEMHRS2010-09-27
2922911544858126K100618MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGYHRS2010-04-20
753201873650683K100618MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGYHRS2010-04-20
2922911060462491K100562LATITUDE ELBOW PROSTHESISJDB2010-06-29
753201567108030K100562LATITUDE ELBOW PROSTHESISJDB2010-06-29
753201865448795K100562LATITUDE ELBOW PROSTHESISJDB2010-06-29
753201634836737K091870TORNIER, PITON FIXATION IMPLANT SYSTEMMBI2009-09-21
2922911879042178K091870TORNIER, PITON FIXATION IMPLANT SYSTEMMBI2009-09-21
753201313627114K090582CALCANEAL FRACTURE PLATE SYSTEMHRS2009-07-02
2922911728950719K090582CALCANEAL FRACTURE PLATE SYSTEMHRS2009-07-02
753201164474282K090289CLAVICLE PLATING SYSTEMHRS2009-06-15
2922911412080897K090289CLAVICLE PLATING SYSTEMHRS2009-06-15
753201487474616K090139ANKLE ARTHRODESIS PLATE SYSTEMHRS2009-10-27
753201580355070K083268TORNIER, INC., INSITE SUTURE ANCHORSMAI2009-02-12
753201502986267K082754AEQUALIS HUMERAL NAIL SYSTEMHSB2009-01-27
2922911922880391K082754AEQUALIS HUMERAL NAIL SYSTEMHSB2009-01-27
753201446353837K082574MAXTORQUE MINI CANNULATED SCREW SYSTEMHWC2008-12-08
2922911635833972K082574MAXTORQUE MINI CANNULATED SCREW SYSTEMHWC2008-12-08
753201604854243K081707AEQUALIS SHOULDER FRACTURE AND SHOULDER SYSTEMSKWS2008-07-17
2922911867190946K081707AEQUALIS SHOULDER FRACTURE AND SHOULDER SYSTEMSKWS2008-07-17
753201122819053K073624MODULAR FOOT SYSTEMHRS2008-03-20
2922911701278252K073624MODULAR FOOT SYSTEMHRS2008-03-20
753201297577131K073331DVO EXTENDED ARTICULATION HUMERAL HEADSHSD2008-02-19
2922911576016700K072710NEXFIX COMPRESSION PINJDW2007-11-08
753201954770759K072710NEXFIX COMPRESSION PINJDW2007-11-08
753201117509616K071147NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEMKWT2007-07-20
753201657217031K070787LATITUDE ELBOW PROTHESISJDB2007-08-24
2922911914095628K070787LATITUDE ELBOW PROTHESISJDB2007-08-24
753201568611244K061400CALCANEAL TRAUMA SYSTEMHRS2006-06-29
2922911764303199K061400CALCANEAL TRAUMA SYSTEMHRS2006-06-29
753202014495433K060988TOTAL AND HEMI SHOULDER SYSTEMKWS2006-12-06
753201018077708K060428CSS CANNULATED SCREW SYSTEMHWC2006-03-07
2922911087750229K060428CSS CANNULATED SCREW SYSTEMHWC2006-03-07
753201342575704K060386NEXA CARPO METACARPAL IMPLANTKYI2006-05-10
2922911996398655K060386NEXA CARPO METACARPAL IMPLANTKYI2006-05-10
753201408981574K060071NEXA COMPRESSION SCREWHWC2006-01-26

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS412019-07-17
KWS172024-12-06
HWC132015-08-04
PHX122024-02-21
JDB102020-08-05
MBI82014-04-04
HSB52023-10-31
HTY42014-08-21
JDR42014-08-21
JDW42007-11-08
PKC32022-09-14
MAI32013-05-13
KWT22025-10-30
HTN22014-01-03
KYI22006-05-10
LXT22005-10-27
PAO12020-09-11
HSD12008-02-19

PMN#