FDA.report

TORNIER, INC.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
16493903000718467TORNIER, INC.1Y2026-01-0110801 Nesbitt Avenue South Bloomington MN US 55437
16493903000718467TORNIER, INC.1Y2020-04-2510801 Nesbitt Avenue South Bloomington MN US 55437

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2922331762161559K990804STAYFUSEHWC1999-04-29
2922331065765862K973453TORNIER CEMENT RESTRICTORJDI1997-12-09
753171251954432K973453TORNIER CEMENT RESTRICTORJDI1997-12-09
2922331640230755K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)PHX2026-01-08
2922331973805867K251686Tornier 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
2922331713007035K232265BLUEPRINT™ Patient Specific InstrumentationPHX2024-02-21
2922331394452460K230352Tornier Humeral Nail and Tornier Long Humeral NailHSB2023-10-31
2922331577976792K220914Tornier Perform Humeral System – FracturePHX2022-10-14
2922331372096470K220418Tornier Perform Humeral System – StemlessPKC2022-09-14
2922331194616089K213124Tomier Perform™ Reversed Glenoid Cannulated GlenospheresPHX2021-10-26
2922331854973689K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific InstrumentationPHX2021-11-12
2922331981062186K201315PERFORM Humeral System – StemPAO2020-09-11
2922331605502150K193247LATITUDE EV™ Total Elbow ArthroplastyJDB2020-08-05
753171306985370K191711ORTHOLOC™ SPS Shoulder Plating SystemHRS2019-07-17
2922331862353959K191711ORTHOLOC™ SPS Shoulder Plating SystemHRS2019-07-17
2922331715359252K191318AEQUALIS FLEX REVIVE Shoulder SystemKWS2019-06-14
753171859170008K191318AEQUALIS FLEX REVIVE Shoulder SystemKWS2019-06-14
2922331436574305K183696Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed GlenoidPHX2019-01-30
753171925978695K183696Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed GlenoidPHX2019-01-30
2922331391668790K182461LATITUDE EV Total Elbow ArthroplastyJDB2018-12-27
753171925049336K182461LATITUDE EV Total Elbow ArthroplastyJDB2018-12-27
753171617414011K181587ORTHOLOC SPS Shoulder Plating SystemHRS2018-10-05
2922331897185069K181587ORTHOLOC SPS Shoulder Plating SystemHRS2018-10-05
753171412851223K181420Aequalis Flex Revive Shoulder SystemKWS2018-09-20
2922331991727029K181420Aequalis Flex Revive Shoulder SystemKWS2018-09-20
753171299436159K171010Latitude EV Total Elbow ArthroplastyJDB2017-08-31
2922331402134835K171010Latitude EV Total Elbow ArthroplastyJDB2017-08-31
753171181720471K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidPHX2016-11-15
2922331740312837K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidPHX2016-11-15
2922331023280719K160975Aequalis PerFORM+ Shoulder SystemKWS2016-06-10
753171473021302K160975Aequalis PerFORM+ Shoulder SystemKWS2016-06-10
753171318527911K150871ForeFoot STP SystemHWC2015-08-04
2922331615378999K150583Aequalis PerFORM+ Shoulder SystemKWS2015-04-23
753172066960752K150583Aequalis PerFORM+ Shoulder SystemKWS2015-04-23
2922331247702283K143552Simpliciti Shoulder SystemPKC2015-03-04
753171824752099K143552Simpliciti Shoulder SystemPKC2015-03-04
753171961166158K142148ORTHOHELIX STAPLE SYSTEMJDR2014-08-21
2922331965103578K142148ORTHOHELIX STAPLE SYSTEMJDR2014-08-21
753171372926929K141301MAXLOCK EXTREME ELBOW FRACTURE SYSTEMHRS2014-07-11
2922331764921269K141301MAXLOCK EXTREME ELBOW FRACTURE SYSTEMHRS2014-07-11
753171643854493K141029TORNIER AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEMPHX2014-06-18
2922331871837364K141029TORNIER AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEMPHX2014-06-18
2922331093623032K141004INTRAOSSEOUS FIXATION SYSTEMHTY2014-08-21
753171642131543K141004INTRAOSSEOUS FIXATION SYSTEMHTY2014-08-21
2922331515537364K133777TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHORMBI2014-04-04
753171788286357K133777TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHORMBI2014-04-04
2922331576666824K133376AEQUALIS HUMERAL NAIL; SIZES 7MM & 8MM X 210, 230, 250, 270MM; LEFT AND RIGHTHSB2013-12-05
753171629094424K133376AEQUALIS HUMERAL NAIL; SIZES 7MM & 8MM X 210, 230, 250, 270MM; LEFT AND RIGHTHSB2013-12-05
2922331041628107K132733ORTHOHELIX SYNDESMOSIS FIXATION DEVICESHTN2014-01-03
753171424021403K132733ORTHOHELIX SYNDESMOSIS FIXATION DEVICESHTN2014-01-03
2922331175771023K132632TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLESMBI2013-09-19
753171998649311K132632TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLESMBI2013-09-19
2922331659206257K132591MAXLOCK EXTREME SYSTEMHRS2013-09-17
753172017982382K132591MAXLOCK EXTREME SYSTEMHRS2013-09-17
2922331181195048K131324MAXTORQUE SCREW SYSTEMHWC2013-05-31
753171637040714K131324MAXTORQUE SCREW SYSTEMHWC2013-05-31
753171036111138K130832ORTHOHELIX STAPLE SYSTEMJDR2013-08-15
2922331554488216K130832ORTHOHELIX STAPLE SYSTEMJDR2013-08-15
2922331528137684K130422PHANTOM FIBER BIOFIBER SUTURENWJ2013-04-04
753171854778243K130422PHANTOM FIBER BIOFIBER SUTURENWJ2013-04-04
2922331727514404K123203MAXLOCK EXTREME SYSTEM MODEL MXLHRS2012-12-14
753171959398983K123203MAXLOCK EXTREME SYSTEM MODEL MXLHRS2012-12-14
2922331382806896K122635TORNIER INSITE FT BIOCOMPOSITE SUTURE ANCHORMAI2013-05-13
753171816101837K122635TORNIER INSITE FT BIOCOMPOSITE SUTURE ANCHORMAI2013-05-13
2922331822000947K122005MAXLOCK EXTREME SYSTEMHRS2012-09-06
753171903567343K122005MAXLOCK EXTREME SYSTEMHRS2012-09-06
753171641270365K121437MINI MAXLOCK EXTREME PLATING SYSTEMHRS2012-06-13
2922331827444124K121437MINI MAXLOCK EXTREME PLATING SYSTEMHRS2012-06-13
2922331638852831K120739AEQUALIS ADJUSTABLE MODULAR REVERSE SHOULDER SYSTEMPHX2012-07-05
753171233327996K120165INTRAOSSEOUS FIXATION SYSTEMHTY2012-04-17
2922331445311560K120165INTRAOSSEOUS FIXATION SYSTEMHTY2012-04-17
2922331019454992K120157MINI MAXLOCK EXTREME PLATING SYSTEMHRS2012-04-10
753171840455136K120157MINI MAXLOCK EXTREME PLATING SYSTEMHRS2012-04-10
2922331316752460K113048MAXLOCK EXTREME SYSTEMHRS2012-01-30
753172023092664K113048MAXLOCK EXTREME SYSTEMHRS2012-01-30
753171012039238K111337TORNIER COLLAGEN COATED BIOFIBER SCAFFOLDFTL2012-01-25
2922331566696074K111337TORNIER COLLAGEN COATED BIOFIBER SCAFFOLDFTL2012-01-25
753171195912347K111041MINI VARIABLE SYSTEMHRS2011-06-06
2922331254069184K111041MINI VARIABLE SYSTEMHRS2011-06-06
753171467665210K110773TORNIER INSITE FT SUTURE ANCHORMBI2011-06-02
2922331657756809K110773TORNIER INSITE FT SUTURE ANCHORMBI2011-06-02
753171128230951K102788TORNIER BIOFIBER SCAFFOLDFTL2011-05-10
753171089274433K102156MAXLOCK EXTREME EXTREMITY PLATING SYSTEM DISTAL RADIUS PLATES AND SCREWSHRS2010-09-30
2922331426815828K101962MINI MAXLOCK EXTREME PLATING SYSTEMHRS2010-09-27
753172047491767K101962MINI MAXLOCK EXTREME PLATING SYSTEMHRS2010-09-27
2922331544858126K100618MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGYHRS2010-04-20
753171873650683K100618MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGYHRS2010-04-20
2922331060462491K100562LATITUDE ELBOW PROSTHESISJDB2010-06-29
753171567108030K100562LATITUDE ELBOW PROSTHESISJDB2010-06-29
753171865448795K100562LATITUDE ELBOW PROSTHESISJDB2010-06-29
753171634836737K091870TORNIER, PITON FIXATION IMPLANT SYSTEMMBI2009-09-21
2922331879042178K091870TORNIER, PITON FIXATION IMPLANT SYSTEMMBI2009-09-21
753171313627114K090582CALCANEAL FRACTURE PLATE SYSTEMHRS2009-07-02
2922331728950719K090582CALCANEAL FRACTURE PLATE SYSTEMHRS2009-07-02
753171164474282K090289CLAVICLE PLATING SYSTEMHRS2009-06-15
2922331412080897K090289CLAVICLE PLATING SYSTEMHRS2009-06-15
753171580355070K083268TORNIER, INC., INSITE SUTURE ANCHORSMAI2009-02-12
2922331922880391K082754AEQUALIS HUMERAL NAIL SYSTEMHSB2009-01-27
753171446353837K082574MAXTORQUE MINI CANNULATED SCREW SYSTEMHWC2008-12-08
2922331635833972K082574MAXTORQUE MINI CANNULATED SCREW SYSTEMHWC2008-12-08
753171122819053K073624MODULAR FOOT SYSTEMHRS2008-03-20
2922331701278252K073624MODULAR FOOT SYSTEMHRS2008-03-20
753171657217031K070787LATITUDE ELBOW PROTHESISJDB2007-08-24
2922331914095628K070787LATITUDE ELBOW PROTHESISJDB2007-08-24
753171863958148K063551AEQUALIS HUMERAL PLATEKTT2006-12-22
753171568611244K061400CALCANEAL TRAUMA SYSTEMHRS2006-06-29
2922331764303199K061400CALCANEAL TRAUMA SYSTEMHRS2006-06-29
753171204139167K060545UNITY HUMERAL PLATEKTT2006-04-21
753171018077708K060428CSS CANNULATED SCREW SYSTEMHWC2006-03-07
2922331087750229K060428CSS CANNULATED SCREW SYSTEMHWC2006-03-07
753171342575704K060386NEXA CARPO METACARPAL IMPLANTKYI2006-05-10
2922331996398655K060386NEXA CARPO METACARPAL IMPLANTKYI2006-05-10
753171408981574K060071NEXA COMPRESSION SCREWHWC2006-01-26
2922331682826090K053408NEXA BONE PLATE AND SCREW SYSTEMHRS2005-12-22
753171424083222K053182DRLOCK DISTAL RADIUS VOLAR SYSTEMHRS2006-02-27
2922331918197091K053182DRLOCK DISTAL RADIUS VOLAR SYSTEMHRS2006-02-27
753171966310126K022726STAYFUSE GT-IPHWC2002-09-06
2922332016212829K022726STAYFUSE GT-IPHWC2002-09-06
7531710032455051969-12-31

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
HRS362019-07-17
PHX122026-01-08
HWC112015-08-04
JDB102020-08-05
KWS92024-12-06
MBI82014-04-04
HSB42023-10-31
JDR42014-08-21
HTY42014-08-21
PKC32022-09-14
MAI32013-05-13
FTL32012-01-25
HTN22014-01-03
NWJ22013-04-04
KTT22006-12-22
KYI22006-05-10
JDI21997-12-09
KWT12025-10-30
PAO12020-09-11

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