Orthofix S R L

FDA Filings

This page includes the latest FDA filings for Orthofix S R L. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number9680825
FEI Number3002807827
NameORTHOFIX SRL
Owner & OperatorORTHOFIX SRL
Contact AddressVIA DELLE NAZIONI 9 --
BUSSOLENGO IT-VR Verona 37012 IT
Official Correspondent
  • GIANLUCA - RICADONA
  • 39-045-6719000-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressVIA DELLE NAZIONI 9
BUSSOLENGO Verona, 37012 IT
Establishment Type
  • Manufacture Medical Device
  • Export Device to the United States But Perform No Other Operation on Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
ORTHOFIX SRL
ORTHOFIX 67760350R2024-05-15
ORTHOFIX SRL
ORTHOFIX 67760325R2024-05-15
ORTHOFIX SRL
ORTHOFIX 67760300R2024-05-15
ORTHOFIX SRL
ORTHOFIX 67760275R2024-05-15
ORTHOFIX SRL
ORTHOFIX 67760250R2024-05-15
ORTHOFIX SRL
ORTHOFIX 67750350R2024-05-15
ORTHOFIX SRL
ORTHOFIX 67750325R2024-05-15
ORTHOFIX SRL
ORTHOFIX 67750300R2024-05-15
ORTHOFIX SRL
ORTHOFIX 67750275R2024-05-15
ORTHOFIX SRL
ORTHOFIX 67750250R2024-05-15
ORTHOFIX SRL
ORTHOFIX 67745230R2024-05-15
ORTHOFIX SRL
ORTHOFIX 67745205R2024-05-15
ORTHOFIX SRL
ORTHOFIX 67745190R2024-05-15
ORTHOFIX SRL
ORTHOFIX 67745175R2024-05-15
ORTHOFIX SRL
ORTHOFIX 67745160R2024-05-15
ORTHOFIX SRL
ORTHOFIX 67740230R2024-05-15
ORTHOFIX SRL
ORTHOFIX 67740205R2024-05-15
ORTHOFIX SRL
ORTHOFIX 67740180R2024-05-15
ORTHOFIX SRL
ORTHOFIX 67740155R2024-05-15
ORTHOFIX SRL
ORTHOFIX 67740130R2024-05-15
ORTHOFIX SRL
ORTHOFIX 67735150R2024-05-15
ORTHOFIX SRL
ORTHOFIX 67735140R2024-05-15
ORTHOFIX SRL
ORTHOFIX 67735130R2024-05-15
ORTHOFIX SRL
ORTHOFIX 67735120R2024-05-15
ORTHOFIX SRL
ORTHOFIX 67735100R2024-05-15
ORTHOFIX SRL
ORTHOFIX 99-67740180R2024-05-15
ORTHOFIX SRL
ORTHOFIX 99-67740155R2024-05-15
ORTHOFIX SRL
ORTHOFIX 99-67740130R2024-05-15
ORTHOFIX SRL
ORTHOFIX 99-67735150R2024-05-15
ORTHOFIX SRL
ORTHOFIX 99-67735140R2024-05-15
ORTHOFIX SRL
ORTHOFIX 99-67735130R2024-05-15
ORTHOFIX SRL
ORTHOFIX 99-67735120R2024-05-15
ORTHOFIX SRL
ORTHOFIX 99-67735100R2024-05-15
ORTHOFIX SRL
ORTHOFIX 99-600038002024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037992024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037982024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037972024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037962024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037952024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037942024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037932024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037922024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037912024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037902024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037892024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037882024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037872024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037862024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037852024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037842024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037832024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037822024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037812024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037802024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037792024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037782024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037772024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037762024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037752024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037742024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037732024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037722024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037712024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037702024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037692024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037682024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037672024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037662024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037652024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037642024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037632024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037622024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037612024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037602024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037592024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037582024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037572024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037562024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037552024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037542024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037532024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037522024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037512024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037502024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037492024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037482024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037472024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037462024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037452024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037442024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037432024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037422024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037412024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037402024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037392024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037382024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037372024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037362024-05-08
ORTHOFIX SRL
ORTHOFIX 99-600037352024-05-08
ORTHOFIX SRL
ORTHOFIX 99-100132024-05-08
Orthofix Srl
JuniOrtho Plating Systemâ„¢2022-01-18
Orthofix SRL
TrueLok Evo2021-11-05
Orthofix SRL
SOLE Medial Column Fusion Plate2021-04-20
Orthofix Srl
JPS JuniOrtho Plating System2020-05-22
ORTHOFIX SRL
OSCAR PRO2020-03-12
ORTHOFIX SRL
RIVALTM View Plating System? and Reduce Fracture Plating System?2019-06-10
ORTHOFIX SRL
RIVALTM View Plating System? and Reduce Fracture Plating System?2019-06-10
Orthofix Srl
RIVAL View Plating Systems And Reduce Fracture Plating Systems2019-06-07
ORTHOFIX SRL
Guided Growth Plate System Plus2018-05-16
Orthofix Srl
Guided Growth Plate System Plus2018-05-15
ORTHOFIX SRL
OSCAR2018-05-11
ORTHOFIX SRL
OSCAR, MODEL OE3000DB2018-05-11
ORTHOFIX SRL
OSCAR2018-05-11
ORTHOFIX SRL
OSCAR, MODEL OE3000DB2018-05-11
ORTHOFIX SRL
OSCAR2018-05-11
ORTHOFIX SRL
OSCAR, MODEL OE30002018-05-11
ORTHOFIX SRL
Agile Nail2018-04-24
Orthofix Srl
Agile Nail2018-04-23
ORTHOFIX SRL
G-Beam Fusion Beaming System2018-03-06
Orthofix Srl
G-Beam Fusion Beaming System2018-02-07
ORTHOFIX SRL
Guided Growth Plate System2018-01-10
ORTHOFIX SRL
Guided Growth Plate System Plus2018-01-10
Orthofix Srl
Guided Growth Plate System Plus2018-01-09
ORTHOFIX SRL
ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System2017-12-14
ORTHOFIX SRL
Chimaera Hip Fracture System2017-12-14
Orthofix Srl
ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System2017-12-07
ORTHOFIX SRL
Orthofix MJ-FLEX THE NEW METAIZEAU NAIL2017-11-17
ORTHOFIX SRL
MJ-Flex2017-11-17
ORTHOFIX SRL
Orthofix MJ-FLEX THE NEW METAIZEAU NAIL2017-11-17
ORTHOFIX SRL
MJ-Flex2017-11-17
Orthofix Srl
Orthofix MJ-FLEX THE NEW METAIZEAU NAIL2017-11-16
ORTHOFIX SRL
Galaxy UNYCO System2017-10-30
ORTHOFIX SRL
Galaxy UNYCO Femur&Knee Bridging2017-10-30
Orthofix Srl
Galaxy UNYCO System2017-10-12
ORTHOFIX SRL
Rival Bite Compression Screws2017-06-15
ORTHOFIX SRL
Rival View Plating System2017-06-06
ORTHOFIX SRL
Rival Reduce Fracture Plating System2017-06-06
ORTHOFIX SRL
Rival View Plating System2017-06-06
ORTHOFIX SRL
Rival Reduce Fracture Plating System2017-06-06
ORTHOFIX SRL
Rival View Plating System2017-06-06
ORTHOFIX SRL
Rival Reduce Fracture Plating System2017-06-06
ORTHOFIX SRL
True Lok System2017-05-11
ORTHOFIX SRL
Orthofix TrueLok Hexapod System (TL-HEX) V2.02017-05-11
ORTHOFIX SRL
True Lok System2017-05-11
ORTHOFIX SRL
Orthofix TrueLok Hexapod System (TL-HEX) V2.02017-05-11
Orthofix Srl
Orthofix TrueLok Hexapod System (TL-HEX) V2.02017-05-10
ORTHOFIX SRL
Orthofix Chimaera Hip Fracture System - Trochanteric Nailing System2017-01-25
ORTHOFIX SRL
Chimaera Hip Fracture System2017-01-25
ORTHOFIX SRL
ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System2017-01-24
ORTHOFIX SRL
OSCAR 32016-12-13
ORTHOFIX SRL
OSCAR 32016-12-13
ORTHOFIX SRL
Contours VPS Volar Plating System2016-11-03
ORTHOFIX SRL
Contours VPS III Volar Plating System (bone plate)2016-11-03
ORTHOFIX SRL
Contours VPS Volar Plating System2016-11-03
ORTHOFIX SRL
Contours VPS III Volar Plating System (bone plate)2016-11-03
ORTHOFIX SRL
Orthofix Volar Distal Radial Plate2016-11-03
ORTHOFIX SRL
Contours VPS Volar Plating System2016-11-03
ORTHOFIX SRL
Contours Lapidus Plating System2016-02-24
ORTHOFIX SRL
Galaxy UNYCO2016-01-11
ORTHOFIX SRL
Galaxy UNYCO System2016-01-11
ORTHOFIX SRL
Galaxy UNYCO System2016-01-06
ORTHOFIX SRL
GUIDED GROWTH SYSTEM EIGHT PLATE, QUAD-PLATE (STAINLESS STEEL)2015-11-06
ORTHOFIX SRL
GUIDED GROWTH PLATE SYSTEM2015-11-06
ORTHOFIX SRL
GUIDED GROWTH SYSTEM2015-11-06
ORTHOFIX SRL
GUIDED GROWTH PLATE SYSTEM2015-11-06
ORTHOFIX SRL
Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.42015-09-28
ORTHOFIX SRL
ANKLE HINDFOOT NAILING SYSTEM2015-08-27
ORTHOFIX SRL
ANKLE COMPRESSION NAILING SYSTEM2015-08-27
ORTHOFIX SRL
GALAXY UNYCO2014-12-11
ORTHOFIX SRL
GALAXY UNYCO DIAPHYSEAL TIBIA KIT2014-12-11
ORTHOFIX SRL
GALAXY WRIST2014-12-11
ORTHOFIX SRL
GALAXY FIXATION SYSTEM2014-12-11
Orthofix Srl
Orthofix True Lok Hexapod System VI.32014-12-10
ORTHOFIX SRL
ORTHOFIX GALAXY WRIST2014-12-08
ORTHOFIX SRL
ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT2014-12-05
ORTHOFIX SRL
ORTHOFIX ANKLE HINDFOOT NAILING SYSTEM2014-11-12
ORTHOFIX SRL
ORTHOFIX TL-HEX TRUE LOK HEXALOBE SYSTEM (TL-HEX)2014-09-02
ORTHOFIX SRL
CONTOURS PROXIMAL HUMERAL PLATE (PHP)2013-01-21
ORTHOFIX SRL
GUIDED GROWTH PLATE2012-09-24
ORTHOFIX SRL
GUIDED GROWTH PLATE SYSTEM2012-09-24
ORTHOFIX SRL
ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)2012-09-20
ORTHOFIX SRL
GALAXY FIXATION SYSTEM2012-09-14
ORTHOFIX SRL
ORTHOFIX GALAXY FIXATION SYSTEM2012-09-04
ORTHOFIX SRL
TRUE LOK SYSTEM2010-12-27
ORTHOFIX SRL
TRUE LOK PLUS SYSTEM2010-12-27
ORTHOFIX SRL
HA BONE SCREWS2007-12-21
ORTHOFIX SRL
STAINLESS STEEL TIBIAL NAILING SYSTEM2007-12-21
ORTHOFIX SRL
XCALIBER EXTERNAL FIXATOR2007-12-21
ORTHOFIX SRL
XCALIBER BONE SCREWS2007-12-21
ORTHOFIX SRL
TITANIUM SCREWS2007-12-21
ORTHOFIX SRL
SMALL BLUE D.A.F.2007-12-21
ORTHOFIX SRL
RADIOLUCENT WRIST FIXATOR2007-12-21
ORTHOFIX SRL
PROCALLUS FIXATOR2007-12-21
ORTHOFIX SRL
PREFIX FIXATOR2007-12-21
ORTHOFIX SRL
PERTROCHANTERIC FIXATOR2007-12-21
ORTHOFIX SRL
PENNIG MINIFIXATOR2007-12-21
ORTHOFIX SRL
PENNIG DYNAMIC WRIST FIXATOR2007-12-21
ORTHOFIX SRL
PELVIC FIXATOR2007-12-21
ORTHOFIX SRL
PAEDIATRIC LIMB RECONSTRUCTION SYSTEM2007-12-21
ORTHOFIX SRL
MINIRAIL SYSTEM2007-12-21
ORTHOFIX SRL
ELBOW FIXATOR2007-12-21
ORTHOFIX SRL
DYNAMIC AXIAL FIXATOR2007-12-21
ORTHOFIX SRL
BONE SCREWS2007-12-21
ORTHOFIX SRL
ADVANCED LIMB RECONSTRUCTION SYSTEM2007-12-21
ORTHOFIX SRL
ADULT LIMB RECONSTRUCTION SYSTEM2007-12-21
ORTHOFIX SRL
SHEFFIELD RING FIXATOR2007-12-21
ORTHOFIX SRL
HYBRID FIXATOR SYSTEM2007-12-21
ORTHOFIX SRL
FRAGMENT FIXATION SYSTEM2007-12-21
ORTHOFIX SRL
LSP TITANIUM HUMERAL PLATE2007-12-21
ORTHOFIX SRL
FLEXIBLE REAMER2007-05-14
ORTHOFIX SRL
FLEXIBLE REAMER SYSTEM2007-05-14
ORTHOFIX SRL
PERCUTANEOUS COMPRESSION PLATE (PC.CP)2007-02-13
ORTHOFIX SRL
PORD DEVICE2007-02-13
ORTHOFIX SRL
ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP2006-11-13
ORTHOFIX SRL
ORTHOFIX TITANIUM NAILING SYSTEMS2005-12-12
ORTHOFIX SRL
MIOT PLATING SYSTEM2005-11-25
ORTHOFIX SRL
MIOT PLATING SYSTEM2005-09-06
ORTHOFIX SRL
Orthofix Rival Orthopedic Surgical Instruments2000-04-06
ORTHOFIX SRL
Orthofix Orthopedic Surgical Instruments2000-04-06
ORTHOFIX SRL
ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING1998-03-18
ORTHOFIX SRL
ORTHOFIX FEMORAL NAILING SYTEM1997-12-19
ORTHOFIX SRL
ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM1995-04-04

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