FDA.reportPublic FDA data

External orthopaedic fixation system, single-use, sterile

Definition
An assembly of sterile devices designed to stabilize fractured bones of the lower limbs to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur and tibia, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device.
GUDID devices
850
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00885556052990Jet-XSmith & Nephew, Inc.719312012015-08-29
00885556055175Jet-XSmith & Nephew, Inc.719312002015-08-29
08032909623600ST.A.R. 90 F4CITIEFFE SRLClamp2015-10-21
08032909623624ST.A.R. 90 F4CITIEFFE SRLBone screw holder2015-10-21
08032909623792ST.A.R. 90 F4CITIEFFE SRLKnee external fixator2015-10-21
08032909623952ST.A.R. 90 F4CITIEFFE SRLMedial screws arm kit2015-10-21
08032909624140ST.A.R. 90 F4CITIEFFE SRLRadiolucent straight rod ø14mm L120mm2015-10-21
08032909624157ST.A.R. 90 F4CITIEFFE SRLRadiolucent straight rod ø14mm L160mm2015-10-21
08032909624164ST.A.R. 90 F4CITIEFFE SRLRadiolucent straight rod ø14mm L200mm2015-10-21
08032909624171ST.A.R. 90 F4CITIEFFE SRLRadiolucent straight rod ø14mm L240mm2015-10-21
08032909624188ST.A.R. 90 F4CITIEFFE SRLRadiolucent straight rod ø14mm L280mm2015-10-21
08032909624195ST.A.R. 90 F4CITIEFFE SRLRadiolucent straight rod ø14mm L320mm2015-10-21
08032909624201ST.A.R. 90 F4CITIEFFE SRLRadiolucent straight rod ø14mm L360mm2015-10-21
08032909624218ST.A.R. 90 F4CITIEFFE SRLRadiolucent straight rod ø14mm L400mm2015-10-21
08032909624713ST.A.R. 90 F4CITIEFFE SRLHA cortical bone screw ø4mm L120-34mm2015-10-21
08032909624720ST.A.R. 90 F4CITIEFFE SRLHA cortical bone screw ø4mm L150-40mm2015-10-21
08032909624744ST.A.R. 90 F4CITIEFFE SRLHA cortical bone screw ø5mm L120-34mm2015-10-21
08032909624751ST.A.R. 90 F4CITIEFFE SRLHA cortical bone screw ø5mm L150-40mm2015-10-21
08032909624768ST.A.R. 90 F4CITIEFFE SRLHA cortical bone screw ø5mm L180-50mm2015-10-21
08032909624775ST.A.R. 90 F4CITIEFFE SRLHA cortical bone screw ø6mm L150-40mm2015-10-21
08032909624782ST.A.R. 90 F4CITIEFFE SRLHA cortical bone screw ø6mm L180-50mm2015-10-21
08032909624799ST.A.R. 90 F4CITIEFFE SRLHA cortical bone screw ø6mm L200-60mm2015-10-21
08032909624805ST.A.R. 90 F4CITIEFFE SRLHA cortical bone screw ø5mm L100-34mm2015-10-21
08032909624812ST.A.R. 90 F4CITIEFFE SRLHA cortical bone screw ø5mm L120-34mm2015-10-21
08032909624829ST.A.R. 90 F4CITIEFFE SRLHA cortical bone screw ø5mm L150-40mm2015-10-21
08032909624836ST.A.R. 90 F4CITIEFFE SRLHA cortical bone screw ø5mm L180-50mm2015-10-21
08032909624843ST.A.R. 90 F4CITIEFFE SRLHA cortical bone screw ø6mm L150-40mm2015-10-21
08032909624850ST.A.R. 90 F4CITIEFFE SRLHA cortical bone screw ø6mm L180-50mm2015-10-21
08032909624867ST.A.R. 90 F4CITIEFFE SRLHA cortical bone screw ø6mm L200-60mm2015-10-21
08032909624881DOLPHIXCITIEFFE SRLBasic kit2015-10-21
08032909624898DOLPHIXCITIEFFE SRLClamp with bone screw ø6mm L160mm2015-10-21
08032909624904DOLPHIXCITIEFFE SRLRod to rod clamp2015-10-21
08032909624911DOLPHIXCITIEFFE SRLRadiolucent rod ø12mm L300mm2015-10-21
08032909624928DOLPHIXCITIEFFE SRLRadiolucent rod ø12mm L400mm2015-10-21
08032909624935DOLPHIXCITIEFFE SRLBone screw ø6mm L200mm2015-10-21
08032909624997DOLPHIXCITIEFFE SRLClamp with bone screw ø6mm L200mm2015-10-21
08032909625031ST.A.R. 90 F4CITIEFFE SRLElbow fixator extension2015-10-21
08032909625055DOLPHIXCITIEFFE SRLPilon fractures kit2015-10-21
08032909625079DOLPHIXCITIEFFE SRLClamp with transfixing bone screw ø5mm L220mm2015-10-21
08032909625109DOLPHIXCITIEFFE SRLClamp with transfixing bone screw ø6mm L200mm2018-03-20
08032909625116DOLPHIXCITIEFFE SRLClamp with transfixing bone screw ø6mm L220mm2018-03-20
08032909625123DOLPHIXCITIEFFE SRLClamp with transfixing bone screw ø6mm L240mm2018-03-20
08032909625130DOLPHIXCITIEFFE SRLClamp with transfixing bone screw ø6mm L260mm2018-03-20
08032909625147DOLPHIXCITIEFFE SRLClamp for ø4mm bone screw2015-10-21
08032909625154DOLPHIXCITIEFFE SRLClamp for ø5mm bone screw2015-10-21
08032909625161DOLPHIXCITIEFFE SRLClamp for ø6mm bone screw2015-10-21
08032909625178DOLPHIXCITIEFFE SRLRadiolucent rod ø12mm L150mm2015-10-21
08032909625185DOLPHIXCITIEFFE SRLRadiolucent rod ø12mm L200mm2015-10-21
08032909625215DOLPHIXCITIEFFE SRLBone screw ø6mm L160mm2015-10-21
08032909625222DOLPHIXCITIEFFE SRLTransfixing bone screw ø5mm L200mm2015-10-21
08032909625239DOLPHIXCITIEFFE SRLTransfixing bone screw ø5mm L220mm2015-10-21
08032909625246DOLPHIXCITIEFFE SRLTransfixing bone screw ø5mm L240mm2015-10-21
08032909625253DOLPHIXCITIEFFE SRLTransfixing bone screw ø5mm L260mm2015-10-21
08032909625260DOLPHIXCITIEFFE SRLTransfixing bone screw ø6mm L200mm2015-10-21
08032909625277DOLPHIXCITIEFFE SRLTransfixing bone screw ø6mm L220mm2015-10-21
08032909625284DOLPHIXCITIEFFE SRLTransfixing bone screw ø6mm L240mm2015-10-21
08032909625291DOLPHIXCITIEFFE SRLTransfixing bone screw ø6mm L260mm2015-10-21
08032909628421DOLPHIXCITIEFFE SRLMetatarsal accessory kit2015-10-21
08032909628438DOLPHIXCITIEFFE SRLClamp with bone screw ø5mm L120mm2018-09-28
08032909629572DOLPHIXCITIEFFE SRLSoft tissue protection guide2015-12-24
08051739530575DOLPHIXCITIEFFE SRLL-Shaped Rod ø12mm L70x250mm2018-09-17
08051739531268DOLPHIXCITIEFFE SRLClamp with SS bone screw ø4mm L120-30mm2018-10-17
08051739531275DOLPHIXCITIEFFE SRLClamp with SS bone screw ø5mm L180-40mm2018-10-17
08051739531282DOLPHIXCITIEFFE SRLClamp with SS bone screw ø6mm L200-45mm2018-10-17
08051739531299DOLPHIXCITIEFFE SRLSS bone screw ø4mm L120-30mm2018-10-17
08051739531305DOLPHIXCITIEFFE SRLSS bone screw ø5mm L180-40mm2018-10-17
08051739531312DOLPHIXCITIEFFE SRLSS Bone screw ø6mm L200-45mm2018-10-17
08051739531725DOLPHIXCITIEFFE SRLClamp with SS bone screw ø4mm L120-30mm, Low Refle2019-01-09
08051739531732DOLPHIXCITIEFFE SRLClamp with SS bone screw ø5mm L180-40mm, Low Refle2019-01-09
08051739531749DOLPHIXCITIEFFE SRLClamp with SS bone screw ø6mm L200-45mm, Low Refle2019-01-09
08051739531756DOLPHIXCITIEFFE SRLSS Bone screw ø4mm L120-30mm, Low Reflex2018-12-15
08051739531763DOLPHIXCITIEFFE SRLSS Bone screw ø5mm L180-40mm, Low Reflex2018-12-15
08051739531770DOLPHIXCITIEFFE SRLSS Bone screw ø6mm L200-45mm, Low Reflex2018-12-15
08051739531787DOLPHIXCITIEFFE SRLOmega-shaped Rod ø12mm L300mm - Drill brace2018-12-15
08052990971275DOLPHIXCITIEFFE SRLU-Shaped Rod ø12mm2017-04-14
08052990972234DOLPHIXCITIEFFE SRLRadiolucent rod ø12mm L500mm2017-06-19
08052990972241DOLPHIXCITIEFFE SRLRadiolucent rod ø12mm L600mm2017-06-19
08052990972258DOLPHIXCITIEFFE SRLRadiolucent rod ø12mm L650mm2017-06-19
08052990972296DOLPHIXCITIEFFE SRLBasic kit2017-06-19
08052990972302DOLPHIXCITIEFFE SRLPilon fractures kit2017-06-19