FDA.report

ORTHOFIX SRL

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
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 GUDIDProductPhoneEmail
18052469476055MINI-FIXATION SYSTEMS - CALCFIX PLUS CALCANEAL FIXATOR0456719000info@orthofix.it
18052469476086MINI-FIXATION SYSTEMS - CALCFIX PLUS CALCANEAL FIXATOR STERILE0456719000info@orthofix.it
18052469476406MINI-FIXATION SYSTEMS - CALCFIX PLUS CALCANEAL FIXATOR SET STERILE0456719000info@orthofix.it
18053504362852VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM - RIVAL TI NON-LOCKING SCREW L8MM THREAD D2.0MM STERILE+0390456719000info@orthofix.it

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
499561576467495K983814GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEMJDO1999-01-14
499561350399495K974186ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATINGJDW1998-03-18
499561331720571K973944ORTHOFIX FEMORAL NAILING SYTEMHSB1997-12-19
499561926829554K961027ORTHOFIX TIBIAL NAILING SYSTEMHSB1996-05-08
499561438260842K955848ORTHOFIX MODULSYSTEMJDW1996-03-20
499561833426412K944092ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEMJEC1995-04-04
499561296922497K941048TRUE/LOK MONOLATERAL/BILATERAL FIXATORLXT1994-10-03
499561035328936K260146
499561203340521K253991Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAAHSB2026-05-08
499561732123734K250112FitboneTM TrochantericHSB2025-04-10
499561531985031K242861TrueLok ElevateKTT2024-12-03
499561990155068K242270OrthoNext Platform SystemQIH2024-12-19
499561430021510K233867Fitbone TrochantericHSB2024-06-18
499561482228464K232648RODEO Telescopic NailHSB2024-05-03
499561278747289K232169FITBONE® Transport and Lengthening SystemHSB2024-03-22
499561437021969K213572JuniOrtho Plating System™HWC2022-01-18
499561564794950K212044TrueLok EvoKTT2021-11-05
499561119660979K210157SOLE Medial Column Fusion PlateHRS2021-04-20
499561643769564K203399FITBONE(R) TAAHSB2021-02-17
499561996045716K202519OrthoNext Platform SystemLLZ2020-10-27
499561381108124K200246JPS JuniOrtho Plating SystemHRS2020-05-22
499561266556791K190388RIVAL View Plating Systems and Reduce Fracture Plating SystemsHRS2019-06-07
499561707311729K180624Guided Growth Plate System PlusOBT2018-05-15
499561718586754K173458ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing SystemHSB2017-12-07
499561471446519K173051Orthofix MJ-FLEX THE NEW METAIZEAU NAILHTY2017-11-16
499561242845374K172699Agile NailHSB2018-04-23
499561427595679K172698G-Beam Fusion Beaming SystemHWC2018-02-07
499561192845261K172183Guided Growth Plate System PlusOBT2018-01-09
499561903072283K170650Orthofix TrueLok Hexapod System (TL-HEX) V2.0KTT2017-05-10
499561966285551K170146Galaxy UNYCO SystemKTT2017-10-12
499562067115851K163368FITBONE TAAHSB2017-01-26
499561377708285K161466ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing SystemHSB2017-01-24
499561919260371K153233Galaxy UNYCO SystemKTT2016-01-06
499561297226383K142135REDUCE FRACTURE PLATING SYSTEM LINE EXTENSIONHRS2014-08-28
499561112014719K142052ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KITKTT2014-12-05
499561164641225K141760ORTHOFIX GALAXY WRISTKTT2014-12-08
499561826012370K141571ORTHOFIX ANKLE HINDFOOT NAILING SYSTEMHSB2014-11-12
499561959140998K140876VIEW PLATING SYSTEM,REDUCE FRACTURE PLATING SYSTEM,BONE SCREWHRS2014-07-22
499561756728039K132893EDGE ORTHOPAEDICS BITE COMPRESSION SCREWHWC2013-11-20
499561743535792K122541ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)KTW2012-09-20
499561814798152K113770ORTHOFIX GALAXY FIXATION SYSTEMKTT2012-09-04
499561977520612K110805GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL)OBT2011-06-21
499561886228997K102201CONTOURS LAPIDUS PLATING SYSTEMHRS2010-12-15
499561008470473K101936CONTOURS VSP III VOLAR PLATING SYSTEMHRS2010-10-20
499561714634946K093805OSCAR 3JDX2010-02-19
499561526991027K093442GUIDED GROWTH SYSTEMOBT2010-06-10
499561767560410K062920ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSPKTW2006-11-13
499561721156102K053261ORTHOFIX TITANIUM NAILING SYSTEMSHSB2005-12-12
499561962792756K051945MIOT PLATING SYSTEMHRS2005-09-06
499562033038772K051053OSCAR, MODEL OE3000DBJDX2005-07-21
499561284307115K042766ORTHOFIX VOLAR DISTAL RADIAL PLATEHRS2004-11-16
499561079470379K031493GROWTH GUIDANCE PLATEHRS2003-11-20
499561128594401K021502OSCAR, MODEL OE3000LZV2002-06-06
499561131902725
499561183624098
499561290000320
499561302567432
499561349943288
499561529522694
499561552934004
499561566810452
499561580618868
499561591158311
499561592656893
499561605495116
499561689656674
499561700394737
499561724773279
499561845717776
499561857110290
499561883404359

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
HSB142026-05-08
HRS102021-04-20
KTT82024-12-03
OBT42018-05-15
HWC32022-01-18
KTW22012-09-20
JDX22010-02-19
JDW21998-03-18
QIH12024-12-19
LLZ12020-10-27
HTY12017-11-16
LZV12002-06-06
JDO11999-01-14
JEC11995-04-04
LXT11994-10-03

PMN

GUDID

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