FDA.reportPublic FDA data

ORTHOFIX US LLC

Matched from indexed company URL: Orthofix Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
21834492183449ORTHOFIX US LLC1Y2026-01-013451 Plano Parkway Lewisville TX US 75056
96808253002807827ORTHOFIX SRL1N2026-01-01VIA DELLE NAZIONI 9 BUSSOLENGO Verona IT 37012

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
18053504361176TRUELOK SYSTEM - 8MM HALF PIN BOLT WRENCH+0390456719000info@orthofix.it
18059015376654MINIRAL - MINIRAIL TRAY BASE+0390456719000info@orthofix.it
18059015376661MINIRAL - MINIRAIL TRAY LID+0390456719000info@orthofix.it
18257200066421Orthofix Proview - ACMI Adapter CAble Extension MIS1(214)937-3199osi-customerservice@orthofix.c
18257200066421Orthofix Proview - ACMI Adapter CAble Extension MIS1(214)937-3199osi-customerservice@orthofix.com
18257200066438Orthofix Proview - Light Source Clip Expandable Retractor1(214)937-3199osi-customerservice@orthofix.c
18257200066438Orthofix Proview - Light Source Clip Expandable Retractor1(214)937-3199osi-customerservice@orthofix.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1189391521193336P850007PHYSIO-STIM(TM) I & II MODEL 6000 & 7000LOF1986-02-21
1189392036814692P210035AccelStimTM Bone Growth StimulatorLOF2022-05-03
1189391018371565P170036M6-C Artificial Cervical DiscMJO2019-02-06
1189391316985199P030034CERVICAL-STIM MODEL 505L CERVICAL FUSION SYSTEMLOF2004-12-23
1189391276477117K994217BLACKSTONE SPINAL FIXATION SYSTEMMNH2000-02-28
1189391033786031K983814GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEMJDO1999-01-14
499561576467495K983814GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEMJDO1999-01-14
1189391264173219K974885BLACKSTONE MEDICAL INC. ANTERIOR CERVICAL PLATE SYSTEMKWQ1998-06-17
499561350399495K974186ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATINGJDW1998-03-18
1189391578409811K974186ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATINGJDW1998-03-18
1189391307133538K973944ORTHOFIX FEMORAL NAILING SYTEMHSB1997-12-19
499561331720571K973944ORTHOFIX FEMORAL NAILING SYTEMHSB1997-12-19
1189391454373460K972768BLACKSTONE MEDICAL, INC. LAPAROSCOPIC DISC REMOVAL SYSTEMHRX1997-09-25
1189391687159133K961725OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISIONJDX1996-08-01
499561926829554K961027ORTHOFIX TIBIAL NAILING SYSTEMHSB1996-05-08
1189392048541395K961027ORTHOFIX TIBIAL NAILING SYSTEMHSB1996-05-08
499561438260842K955848ORTHOFIX MODULSYSTEMJDW1996-03-20
1189392061002009K955848ORTHOFIX MODULSYSTEMJDW1996-03-20
1189391724924888K944092ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEMJEC1995-04-04
499561833426412K944092ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEMJEC1995-04-04
499561296922497K941048TRUE/LOK MONOLATERAL/BILATERAL FIXATORLXT1994-10-03
1189391778727489K941048TRUE/LOK MONOLATERAL/BILATERAL FIXATORLXT1994-10-03
1189391132470581K831576ORTHOFIXJEC1983-06-08
499561035328936K260146FITBONE® TRANSPORT AND LENGTHENING SYSTEMHSB2026-05-19
499561203340521K253991Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAAHSB2026-05-08
1189392056940896K252088Firebird SI Navigation SystemOLO2025-10-31
1189391444837243K250112FitboneTM TrochantericHSB2025-04-10
499561732123734K250112FitboneTM TrochantericHSB2025-04-10
499561531985031K242861TrueLok ElevateKTT2024-12-03
1189391860275782K242861TrueLok ElevateKTT2024-12-03
499561990155068K242270OrthoNext Platform SystemQIH2024-12-19
1189391796780337K241117M6-C™ Single Use, Disposable InstrumentationQLQ2024-06-21
1189391954895752K240749PILLAR SA Ti Spacer System (82-XXX)MAX2024-05-28
1189391150827427K233867Fitbone TrochantericHSB2024-06-18
499561430021510K233867Fitbone TrochantericHSB2024-06-18
499561482228464K232648RODEO Telescopic NailHSB2024-05-03
1189391810978345K232648RODEO Telescopic NailHSB2024-05-03
1189391237237410K232169FITBONE® Transport and Lengthening SystemHSB2024-03-22
499561278747289K232169FITBONE® Transport and Lengthening SystemHSB2024-03-22
1189391038406928K220861M6-C Artificial Cervical Disc Instruments ASQLQ2022-06-02
1189391606383240K213951FORZA XP Expandable Spacer SystemMAX2022-01-05
499561437021969K213572JuniOrtho Plating System™HWC2022-01-18
1189391498341654K213572JuniOrtho Plating System™HWC2022-01-18
499561564794950K212044TrueLok EvoKTT2021-11-05
1189392033085946K212044TrueLok EvoKTT2021-11-05
1189391201201811K2117123° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate SystemKWQ2022-02-11
1189391375038818K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws), Connector System, FIREBIRD SI Fusion SystemNKG2021-07-30
1189391922868729K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer System, FORZA PEEK Spacer System, FORZA PTC Spacer System, FORZA Ti Spacer System, FORZA XP Expandable Spacer System, Lonestar Cervical Standalone System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, PILLAR SA PTC Spacer System, SKYHAWK Lateral Interbody Fusion SystemODP2021-08-31
1189391347556623K210667FIREBIRD SI Fusion SystemOUR2021-03-25
499561119660979K210157SOLE Medial Column Fusion PlateHRS2021-04-20
1189391843261741K210157SOLE Medial Column Fusion PlateHRS2021-04-20
1189392058587438K203576FORZA Ti Spacer SystemMAX2021-03-03
1189391138525062K203399FITBONE(R) TAAHSB2021-02-17
499561643769564K203399FITBONE(R) TAAHSB2021-02-17
1189391891588727K203342CONSTRUX Mini Ti Spacer SystemODP2021-03-18
1189391361915844K203138FIREBIRD SI Fusion SystemOUR2020-11-18
1189391146816593K202949CONSTRUX Mini PEEK Spacer SystemODP2020-10-29
1189391802998109K202666CONSTRUX Mini PTC Spacer SystemODP2020-10-14
499561996045716K202519OrthoNext Platform SystemLLZ2020-10-27
1189391305374253K201664FIREBIRD SI Fusion SystemOUR2020-09-15
1189391072982371K201481Centurion POCT SystemNKG2020-06-15
1189391895616391K200696FIREBIRD SI Fusion SystemOUR2020-04-02
1189391322744297K200606O-Genesis Graft Delivery SystemFMF2020-05-01
1189391314105511K200246JPS JuniOrtho Plating SystemHRS2020-05-22
499561381108124K200246JPS JuniOrtho Plating SystemHRS2020-05-22
1189391729142636K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemODP2020-04-09
1189391265952829K190751Connector SystemNKG2019-05-22
499561266556791K190388RIVAL View Plating Systems and Reduce Fracture Plating SystemsHRS2019-06-07
1189392033236757K190388RIVAL View Plating Systems and Reduce Fracture Plating SystemsHRS2019-06-07
1189391333003410K183342SambaScrew 3D SI Fusion SystemOUR2019-04-30
1189391647044959K180624Guided Growth Plate System PlusOBT2018-05-15
499561707311729K180624Guided Growth Plate System PlusOBT2018-05-15
1189391821024441K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird® NXG Spinal Fixation System; Phoenix® Minimally Invasive Spinal Fixation System; Phoenix® CDX™ Minimally Invasive Spinal Fixation System; JANUS® Midline Fixation Screw; JANUS® Fenestrated ScrewNKB2018-08-24
1189391695744920K180025Centurion POCT SystemNKG2018-01-22
499561718586754K173458ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing SystemHSB2017-12-07
499561471446519K173051Orthofix MJ-FLEX THE NEW METAIZEAU NAILHTY2017-11-16
1189391794564488K173051Orthofix MJ-FLEX THE NEW METAIZEAU NAILHTY2017-11-16
499561242845374K172699Agile NailHSB2018-04-23
1189391791100607K172699Agile NailHSB2018-04-23
1189391025675707K172698G-Beam Fusion Beaming SystemHWC2018-02-07
499561427595679K172698G-Beam Fusion Beaming SystemHWC2018-02-07
1189392038760785K172696FORZA® XP Expandable Spacer SystemMAX2018-01-19
1189391509021325K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemODP2017-11-02
1189391784282942K172194Connector SystemNKG2017-08-18
499561192845261K172183Guided Growth Plate System PlusOBT2018-01-09
1189391637453945K172183Guided Growth Plate System PlusOBT2018-01-09
1189391537653885K172115Navigated Instrument SystemOLO2018-03-08
1189391909075836K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation SystemNKB2017-05-05
1189391051263401K170650Orthofix TrueLok Hexapod System (TL-HEX) V2.0KTT2017-05-10
499561903072283K170650Orthofix TrueLok Hexapod System (TL-HEX) V2.0KTT2017-05-10
1189391405129942K170647Connector SystemNKG2017-05-11
1189391311571315K170146Galaxy UNYCO SystemKTT2017-10-12
499561966285551K170146Galaxy UNYCO SystemKTT2017-10-12
1189391730794090K163523ECHELON CIRCULAR Powered StaplerGDW2017-04-18
1189391406518043K163421syngo.via MI WorkflowsLLZ2017-01-03
1189391863141426K163368FITBONE TAAHSB2017-01-26
499562067115851K163368FITBONE TAAHSB2017-01-26
1189391962014504K162921Navigated Instrument SystemOLO2017-03-13
1189391993113129K162918Atlas Spine Expandable Interbody SystemMAX2017-02-09
1189391334534392K162638CETRA Anterior Cervical Plate SystemKWQ2016-12-16
1189391431393878K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemMAX2016-12-22
499561377708285K161466ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing SystemHSB2017-01-24

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KWQ342022-02-11
HSB292026-05-19
NKB282018-08-24
HRS202021-04-20
MAX192024-05-28
KWP182014-01-30
KTT162024-12-03
ODP152021-08-31
NKG122021-07-30
MNI122008-03-13
MQP122006-02-24
HWC82022-01-18
OBT82018-05-15
OUR72021-03-25
MNH62003-06-26
OLO52025-10-31
OVD42016-09-08
OVE42016-06-17
KTW42012-09-20
JDX42010-02-19
LOF42004-12-23
JDW41998-03-18
JEC31995-04-04
QLQ22024-06-21
LLZ22020-10-27
HTY22017-11-16
NQW22005-02-18
JDO21999-01-14
LXT21994-10-03
QIH12024-12-19
LOF 12022-05-03
FMF12020-05-01
MJO12019-02-06
GDW12017-04-18
LZV12002-06-06
HRX11997-09-25

PMA#

CervicalStim®

2022-06-14

Orthofix, Inc.3451 Plano Parkwaylewisville, TX 75056 PMA NumberP030034 Supplement NumberS017 Date Received03/16/2022 Decision Date06/14/2022 Product Code LOF  Advisory Committee Orthopedic Supplement Typereal-time Process Supplement Reason Change Design/com...

PhysioStim®, SpinalStim®

2022-06-14

Orthofix, Inc.3451 Plano Parkwaylewisville, TX 75056 PMA NumberP850007 Supplement NumberS046 Date Received03/16/2022 Decision Date06/14/2022 Product Code LOF  Advisory Committee Orthopedic Supplement Typereal-time Process Supplement Reason Change Design/com...

AccelStimTM Bone Growth Stimulator

2022-05-03

Orthofix US LLC3451 Plano Parkwaylewisville, TX 75056 PMA NumberP210035 Date Received10/13/2021 Decision Date05/03/2022 Product Code LOF  Advisory Committee Orthopedic Expedited Review Granted? No

62 records. Showing 1-40. Next

PMN#

100 records. Showing 1-40. Next

GUDID#

116 records. Showing 1-40. Next