FDA.reportPublic FDA data

Titan Spine, a Division of Medtronic

Matched from indexed company URL: TITAN SPINE INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30115779403011577940Titan Spine, a Division of Medtronic1N2026-01-018347 N Steven Rd Milwaukee WI US 53223
30063402363006340236TITAN SPINE, INC1N2020-04-256140 W. EXECUTIVE DR SUITE A MEQUON WI US 53092
30115779403011577940TITAN SPINE INC1N2020-04-258347 N Steven Rd Milwaukee WI US 53223
30142827273014282727Titan Spine, INC1N2020-04-254006 Willow Lake Blvd MPHS TN US 38118

GUDID Contact Samples#

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

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
M682534012070Endoskeleton TCS - Interbody Fusion Device Parallel Small 7mm+1(262)242-7801productinfo@titanspine.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1822611511019178K901035FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLEFST1990-04-23
2162951511019178K901035FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLEFST1990-04-23
2781871003652895K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemNKB2026-04-21
2781871512129618K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)NKB2024-03-27
2781871906645057K223494CD Horizon Spinal SystemNKB2023-01-23
2781871838868497K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMAX2022-04-12
2781871064190252K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMAX2021-12-08
2781871670994392K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMAX2020-08-26
681161085964984K192054Endoskeleton TAS PlateOVD2019-08-29
1822611085964984K192054Endoskeleton TAS PlateOVD2019-08-29
2162951085964984K192054Endoskeleton TAS PlateOVD2019-08-29
2781871085964984K192054Endoskeleton TAS PlateOVD2019-08-29
2781871551093119K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion DeviceODP2019-08-16
681161894316569K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion DeviceOVD2020-01-08
1822611894316569K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion DeviceOVD2020-01-08
2162951894316569K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion DeviceOVD2020-01-08
2781871894316569K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion DeviceOVD2020-01-08
681161043235009K191565Endoskeleton TCS Interbody Fusion DeviceOVE2019-08-06
1822611043235009K191565Endoskeleton TCS Interbody Fusion DeviceOVE2019-08-06
2162951043235009K191565Endoskeleton TCS Interbody Fusion DeviceOVE2019-08-06
2781871043235009K191565Endoskeleton TCS Interbody Fusion DeviceOVE2019-08-06
2781871455990889K190840Medtronic Transportation / Sterilization CassettesKCT2019-10-15
2781871141119538K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) DeviceODP2019-02-11
681161856192269K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion DeviceODP2018-02-13
1822611856192269K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion DeviceODP2018-02-13
2162951856192269K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion DeviceODP2018-02-13
2781871856192269K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion DeviceODP2018-02-13
2781871745783130K170399Endoskeleton TO Interbody Fusion Device (IBD)MAX2017-07-06
681161532871330K163269Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion DeviceOVD2017-04-13
1822611532871330K163269Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion DeviceOVD2017-04-13
2162951532871330K163269Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion DeviceOVD2017-04-13
2781871532871330K163269Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion DeviceOVD2017-04-13
681161097715663K153122Endoskeleton(r) TCS SystemOVE2015-12-14
1822611097715663K153122Endoskeleton(r) TCS SystemOVE2015-12-14
2162951097715663K153122Endoskeleton(r) TCS SystemOVE2015-12-14
2781871097715663K153122Endoskeleton(r) TCS SystemOVE2015-12-14
681161615949211K151596Endoskeleton TCS Interbody Fusion DeviceOVE2015-10-09
1822611615949211K151596Endoskeleton TCS Interbody Fusion DeviceOVE2015-10-09
2162951615949211K151596Endoskeleton TCS Interbody Fusion DeviceOVE2015-10-09
2781871615949211K151596Endoskeleton TCS Interbody Fusion DeviceOVE2015-10-09
681161867141710K142940Endoskeleton TCS SystemOVE2015-01-28
1822611867141710K142940Endoskeleton TCS SystemOVE2015-01-28
2162951867141710K142940Endoskeleton TCS SystemOVE2015-01-28
2781871867141710K142940Endoskeleton TCS SystemOVE2015-01-28
681161993981899K142589Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleton TC, Endoskeleton TLMAX2014-10-17
1822611993981899K142589Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleton TC, Endoskeleton TLMAX2014-10-17
2162951993981899K142589Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleton TC, Endoskeleton TLMAX2014-10-17
681162067004005K141953ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TLMAX2014-10-27
1822612067004005K141953ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TLMAX2014-10-27
2162952067004005K141953ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TLMAX2014-10-27
2781872067004005K141953ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TLMAX2014-10-27
681161681490701K140055ENDOSKELETON(R) TL INTERBODY FUSION DEVICEMAX2014-07-02
1822611681490701K140055ENDOSKELETON(R) TL INTERBODY FUSION DEVICEMAX2014-07-02
2162951681490701K140055ENDOSKELETON(R) TL INTERBODY FUSION DEVICEMAX2014-07-02
2781871681490701K140055ENDOSKELETON(R) TL INTERBODY FUSION DEVICEMAX2014-07-02
681161394687755K111626ENDOSKELETON(R) TASOVD2011-09-09
1822611394687755K111626ENDOSKELETON(R) TASOVD2011-09-09
2162951394687755K111626ENDOSKELETON(R) TASOVD2011-09-09
2781871394687755K111626ENDOSKELETON(R) TASOVD2011-09-09
2781871580638816K102807CD HORIZON SPINAL SYSTEMNKB2010-11-17
681161643822827K102067ENDOSKELETON TOMAX2010-11-05
1822611643822827K102067ENDOSKELETON TOMAX2010-11-05
2162951643822827K102067ENDOSKELETON TOMAX2010-11-05
2781871643822827K102067ENDOSKELETON TOMAX2010-11-05
681161431385276K100889ENDOSKELETON TCODP2010-07-29
1822611431385276K100889ENDOSKELETON TCODP2010-07-29
2162951431385276K100889ENDOSKELETON TCODP2010-07-29
2781871431385276K100889ENDOSKELETON TCODP2010-07-29
681161065589739K083714ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD)MAX2009-04-15
1822611065589739K083714ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD)MAX2009-04-15
2162951065589739K083714ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD)MAX2009-04-15
2781871065589739K083714ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD)MAX2009-04-15
681161783470684K080615ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD)MAX2008-06-17
1822611783470684K080615ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD)MAX2008-06-17
2162951783470684K080615ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD)MAX2008-06-17
2781871783470684K080615ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD)MAX2008-06-17
1822611342398284K063729DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00GXZ2007-08-21
2162951342398284K063729DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00GXZ2007-08-21
2781871342398284K063729DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00GXZ2007-08-21
681161376109617K032812ENDOSKELETON TA VERTEBRAL BODY REPLACEMENTMQP2003-12-08
1822611376109617K032812ENDOSKELETON TA VERTEBRAL BODY REPLACEMENTMQP2003-12-08
2162951376109617K032812ENDOSKELETON TA VERTEBRAL BODY REPLACEMENTMQP2003-12-08
2781871376109617K032812ENDOSKELETON TA VERTEBRAL BODY REPLACEMENTMQP2003-12-08
681161188768894
1822611188768894
2162951188768894
1822611248916068
2162951248916068
681161282709390
1822611282709390
2162951282709390
681161292445032
1822611292445032
2162951292445032
681161308820063
1822611308820063
2162951308820063
681161393042257
1822611393042257
2162951393042257
681161409050004
1822611409050004
2162951409050004
681161525628760
1822611525628760
2162951525628760
681161735728633
1822611735728633
2162951735728633
681161934705664
1822611934705664
681161994679059
1822611994679059
2162951994679059
681162034527433
1822612034527433
2162952034527433
2781871019198950
2781871147553981
2781871157361761

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MAX272022-04-12
OVD162020-01-08
OVE162019-08-06
ODP102019-08-16
NKB42026-04-21
MQP42003-12-08
GXZ32007-08-21
FST21990-04-23
KCT12019-10-15

PMN#

GUDID#

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