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
TrueLok Evo2021-11-05
ORTHOFIX SRL
TrueLok 99-50-10450CE2021-06-25
ORTHOFIX SRL
TrueLok 99-56-131802021-06-25
ORTHOFIX SRL
TrueLok 99-56-131602021-06-25
ORTHOFIX SRL
TrueLok 99-56-136652021-06-25
ORTHOFIX SRL
TrueLok 99-56-136602021-06-25
ORTHOFIX SRL
TrueLok 99-56-136552021-06-25
ORTHOFIX SRL
TrueLok 99-56-136502021-06-25
ORTHOFIX SRL
TrueLok 99-56-136402021-06-25
ORTHOFIX SRL
TrueLok 99-56-136352021-06-25
ORTHOFIX SRL
TrueLok 99-56-136302021-06-25
ORTHOFIX SRL
TrueLok 99-56-136252021-06-25
ORTHOFIX SRL
TrueLok 99-56-136202021-06-25
ORTHOFIX SRL
TrueLok 99-56-136102021-06-25
ORTHOFIX SRL
TrueLok 99-56-136002021-06-25
ORTHOFIX SRL
TrueLok 99-56-135902021-06-25
ORTHOFIX SRL
TrueLok 99-56-116102021-06-24
ORTHOFIX SRL
TrueLok 99-56-116002021-06-24
ORTHOFIX SRL
TrueLok 99-56-115902021-06-24
ORTHOFIX SRL
TrueLok 99-56-115802021-06-24
ORTHOFIX SRL
TrueLok 99-56-115702021-06-24
ORTHOFIX SRL
TrueLok 99-56-109802021-06-24
ORTHOFIX SRL
TrueLok 99-56-109702021-06-24
ORTHOFIX SRL
TrueLok 99-56-109602021-06-24
ORTHOFIX SRL
TrueLok 99-56-109502021-06-24
ORTHOFIX SRL
TrueLok 99-56-109402021-06-24
ORTHOFIX SRL
TrueLok 99-56-109302021-06-24
ORTHOFIX SRL
TrueLok 99-56-109202021-06-24
ORTHOFIX SRL
TrueLok 99-56-109102021-06-24
ORTHOFIX SRL
TrueLok 99-56-109002021-06-24
ORTHOFIX SRL
TrueLok 99-56-108902021-06-24
ORTHOFIX SRL
TrueLok 99-56-108602021-06-24
ORTHOFIX SRL
TrueLok 99-56-108402021-06-24
ORTHOFIX SRL
OSCAR PRO O4POWUS2021-06-24
ORTHOFIX SRL
GALAXY FIXATION 99-9390302021-06-23
ORTHOFIX SRL
GALAXY FIXATION 99-9390202021-06-22
ORTHOFIX SRL
GALAXY FIXATION 99-9390102021-06-22
ORTHOFIX SRL
GALAXY FIXATION 99-9360102021-06-22
ORTHOFIX SRL
TrueLok 99-56-135802021-06-22
ORTHOFIX SRL
TrueLok 99-56-126602021-06-22
ORTHOFIX SRL
TrueLok 99-56-126502021-06-22
ORTHOFIX SRL
TrueLok 99-56-126402021-06-22
ORTHOFIX SRL
TrueLok 99-56-126302021-06-22
ORTHOFIX SRL
TrueLok 99-56-126202021-06-22
ORTHOFIX SRL
TrueLok 99-56-126102021-06-22
ORTHOFIX SRL
TrueLok 99-56-126002021-06-22
ORTHOFIX SRL
TrueLok 99-56-125902021-06-22
ORTHOFIX SRL
TrueLok 99-56-125802021-06-22
ORTHOFIX SRL
TrueLok 99-56-116802021-06-22
ORTHOFIX SRL
TrueLok 99-56-116702021-06-22
ORTHOFIX SRL
TrueLok 99-56-116602021-06-22
ORTHOFIX SRL
TrueLok 99-56-116502021-06-22
ORTHOFIX SRL
TrueLok 99-56-116402021-06-22
ORTHOFIX SRL
TrueLok 99-56-116302021-06-22
ORTHOFIX SRL
TrueLok 99-56-116202021-06-22
ORTHOFIX SRL
OSCAR PRO O4TRAY-022021-06-18
ORTHOFIX SRL
OSCAR PRO O4TRAY-012021-06-18
ORTHOFIX SRL
OSCAR PRO O4TRAY2021-06-18
ORTHOFIX SRL
OSCAR PRO O4BEAM2021-06-18
ORTHOFIX SRL
SOLE MEDIAL COLUMN FUSION PLATE 99-8414342021-06-11
ORTHOFIX SRL
SOLE MEDIAL COLUMN FUSION PLATE 99-8414302021-06-11
ORTHOFIX SRL
SOLE MEDIAL COLUMN FUSION PLATE 99-8414282021-06-11
ORTHOFIX SRL
SOLE MEDIAL COLUMN FUSION PLATE 99-8414262021-06-11
ORTHOFIX SRL
SOLE MEDIAL COLUMN FUSION PLATE 99-8414242021-06-11
ORTHOFIX SRL
SOLE MEDIAL COLUMN FUSION PLATE 99-8414222021-06-11
ORTHOFIX SRL
SOLE MEDIAL COLUMN FUSION PLATE 99-8414202021-06-11
ORTHOFIX SRL
SOLE MEDIAL COLUMN FUSION PLATE 99-8414182021-06-11
ORTHOFIX SRL
SOLE MEDIAL COLUMN FUSION PLATE 99-8414162021-06-11
ORTHOFIX SRL
SOLE MEDIAL COLUMN FUSION PLATE 99-8414142021-06-11
ORTHOFIX SRL
SOLE MEDIAL COLUMN FUSION PLATE 99-8414122021-06-11
ORTHOFIX SRL
SOLE MEDIAL COLUMN FUSION PLATE 99-8414102021-06-11
ORTHOFIX SRL
SOLE MEDIAL COLUMN FUSION PLATE 99-8415502021-06-11
ORTHOFIX SRL
SOLE MEDIAL COLUMN FUSION PLATE 99-8415462021-06-11
ORTHOFIX SRL
SOLE MEDIAL COLUMN FUSION PLATE 99-8415422021-06-11
ORTHOFIX SRL
SOLE MEDIAL COLUMN FUSION PLATE 99-8415382021-06-11
ORTHOFIX SRL
SOLE MEDIAL COLUMN FUSION PLATE 99-8415342021-06-11
ORTHOFIX SRL
SOLE MEDIAL COLUMN FUSION PLATE 99-8415302021-06-11
ORTHOFIX SRL
SOLE MEDIAL COLUMN FUSION PLATE 99-8415282021-06-11
ORTHOFIX SRL
SOLE MEDIAL COLUMN FUSION PLATE 99-8415262021-06-11
ORTHOFIX SRL
SOLE MEDIAL COLUMN FUSION PLATE 99-8415242021-06-11
ORTHOFIX SRL
SOLE MEDIAL COLUMN FUSION PLATE 99-8415222021-06-11
ORTHOFIX SRL
SOLE MEDIAL COLUMN FUSION PLATE 99-8415202021-06-11
ORTHOFIX SRL
SOLE MEDIAL COLUMN FUSION PLATE 99-8415182021-06-11
ORTHOFIX SRL
SOLE MEDIAL COLUMN FUSION PLATE 99-8415162021-06-11
ORTHOFIX SRL
SOLE MEDIAL COLUMN FUSION PLATE 99-8415142021-06-11
ORTHOFIX SRL
SOLE MEDIAL COLUMN FUSION PLATE 99-8415122021-06-11
ORTHOFIX SRL
SOLE MEDIAL COLUMN FUSION PLATE 99-8415102021-06-11
ORTHOFIX SRL
SOLE MEDIAL COLUMN FUSION PLATE 99-84050R2021-06-11
ORTHOFIX SRL
SOLE MEDIAL COLUMN FUSION PLATE 99-84040R2021-06-11
ORTHOFIX SRL
SOLE MEDIAL COLUMN FUSION PLATE 99-84030R2021-06-11
ORTHOFIX SRL
SOLE MEDIAL COLUMN FUSION PLATE 99-84020R2021-06-11
ORTHOFIX SRL
SOLE MEDIAL COLUMN FUSION PLATE 99-84010R2021-06-11
ORTHOFIX SRL
SOLE MEDIAL COLUMN FUSION PLATE 99-84050L2021-06-11
ORTHOFIX SRL
SOLE MEDIAL COLUMN FUSION PLATE 99-84040L2021-06-11
ORTHOFIX SRL
SOLE MEDIAL COLUMN FUSION PLATE 99-84030L2021-06-11
ORTHOFIX SRL
SOLE MEDIAL COLUMN FUSION PLATE 99-84020L2021-06-11
ORTHOFIX SRL
SOLE MEDIAL COLUMN FUSION PLATE 99-84010L2021-06-11
ORTHOFIX SRL
SOLE MEDIAL COLUMN FUSION PLATE 1849922021-06-11
ORTHOFIX SRL
SOLE MEDIAL COLUMN FUSION PLATE 1849912021-06-11
ORTHOFIX SRL
SOLE MEDIAL COLUMN FUSION PLATE 99-M314M2021-06-11
ORTHOFIX SRL
SOLE MEDIAL COLUMN FUSION PLATE 99-M311M2021-06-11
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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