FDA.reportPublic FDA data

Flexible bone nail, sterile

Definition
A sterile, bending rod made of metal designed for insertion into the intramedullary canal of a long bone for fracture fixation where flexibility of the implant is desired. It is available in various lengths and diameters for use on lower and upper extremity diaphyseal fractures and some metaphyseal fractures of paediatrics and small-statured/normal adults to provide temporary stabilization of the bone segments/fragments until bone consolidation has been achieved. It is designed to splint the cortices with optimal force and maintain the elastic energy to continually brace against rotational/angular forces of the muscles. It may also reduce the fracture. This is a single-use device.
GUDID devices
107
Last updated
2022-05-03 07:08:29

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
H679475915S0NASynthes GmbH475.915S2015-09-14
H679475920S0NASynthes GmbH475.920S2015-09-14
H679475925S0NASynthes GmbH475.925S2015-09-14
H679475930S0NASynthes GmbH475.930S2015-09-14
H679475935S0NASynthes GmbH475.935S2015-09-14
H679475940S0NASynthes GmbH475.940S2015-09-14
18054242518846MJ-FLEXORTHOFIX SRL12018-03-28
18054242518853MJ-FLEXORTHOFIX SRL12018-03-28
18054242518860MJ-FLEXORTHOFIX SRL12018-03-28
18054242518877MJ-FLEXORTHOFIX SRL12018-03-28
18054242518884MJ-FLEXORTHOFIX SRL12018-03-28
18054242518891MJ-FLEXORTHOFIX SRL12018-03-28
18054242518907MJ-FLEXORTHOFIX SRL12018-03-28
18054242518914MJ-FLEXORTHOFIX SRL12018-03-28
18054242518921MJ-FLEXORTHOFIX SRL12018-03-28
B2213110205111EPIX VANEpix Orthopaedics Inc.3110-205112019-03-05
B2213210205101EPIX Assy, VAN, 10mm Dia, 205mmEpix Orthopaedics Inc.3210-205102019-03-05
B221321028010L1EPIX Assy, Long Nail 10mm x 280mm LeftEpix Orthopaedics Inc.3210-28010L2019-03-05
B221321028010R1EPIX Assy, Long Nail 10mm x 280mm RightEpix Orthopaedics Inc.3210-28010R2019-03-05
B221321030010L1EPIX Assy, Long Nail 10mm x 300mm LeftEpix Orthopaedics Inc.3210-30010L2019-03-05
B221321030010R1EPIX Assy, Long Nail 10mm x 300mm RightEpix Orthopaedics Inc.3210-30010R2019-03-05
B221321032010L1EPIX Assy, Long Nail 10mm x 320mm LeftEpix Orthopaedics Inc.3210-32010L2019-03-05
B221321032010R1EPIX Assy, Long Nail 10mm x 320mm RightEpix Orthopaedics Inc.3210-32010R2019-03-05
B221321034010L1EPIX Assy, Long Nail 10mm x 340mm LeftEpix Orthopaedics Inc.3210-34010L2019-03-05
B221321034010R1EPIX Assy, Long Nail 10mm x 340mm RightEpix Orthopaedics Inc.3210-34010R2019-03-05
B221321036010L1EPIX Assy, Long Nail 10mm x 360mm LeftEpix Orthopaedics Inc.3210-36010L2019-03-05
B221321036010R1EPIX Assy, Long Nail 10mm x 360mm RightEpix Orthopaedics Inc.3210-36010R2019-03-05
B221321038010L1EPIX Assy, Long Nail 10mm x 380mm LeftEpix Orthopaedics Inc.3210-38010L2019-03-05
B221321038010R1EPIX Assy, Long Nail 10mm x 380mm RightEpix Orthopaedics Inc.3210-38010R2019-03-05
B221321040010L1EPIX Assy, Long Nail 10mm x 400mm LeftEpix Orthopaedics Inc.3210-40010L2019-03-05
B221321040010R1EPIX Assy, Long Nail 10mm x 400mm RightEpix Orthopaedics Inc.3210-40010R2019-03-05
B221321042010L1EPIX Assy, Long Nail 10mm x 420mm LeftEpix Orthopaedics Inc.3210-42010L2019-03-05
B221321042010R1EPIX Assy, Long Nail 10mm x 420mm RightEpix Orthopaedics Inc.3210-42010R2019-03-05
B221321044010L1EPIX Assy, Long Nail 10mm x 440mm LeftEpix Orthopaedics Inc.3210-44010L2019-03-05
B221321044010R1EPIX Assy, Long Nail 10mm x 440mm RightEpix Orthopaedics Inc.3210-44010R2019-03-05
B221321046010L1EPIX Assy, Long Nail 10mm x 460mm LeftEpix Orthopaedics Inc.3210-46010L2019-03-05
B221321046010R1EPIX Assy, Long Nail 10mm x 460mm RightEpix Orthopaedics Inc.3210-46010R2019-03-05
B2213212065111EPIX Lag Screw 65mm x 11mmEpix Orthopaedics Inc.3212-065112019-03-05
B2213212070111EPIX Lag Screw 70mm x 11mmEpix Orthopaedics Inc.3212-070112019-03-05
B2213212075111EPIX Lag Screw 75mm x 11mmEpix Orthopaedics Inc.3212-075112019-03-05
B2213212080111EPIX Lag Screw 80mm x 11mmEpix Orthopaedics Inc.3212-080112019-03-05
B2213212085111EPIX Lag Screw 85mm x 11mmEpix Orthopaedics Inc.3212-085112019-03-05
B2213212090111EPIX Lag Screw 90mm x 11mmEpix Orthopaedics Inc.3212-090112019-03-05
B2213212095111EPIX Lag Screw 95mm x 11mmEpix Orthopaedics Inc.3212-095112019-03-05
B2213212100111EPIX Lag Screw 100mm x 11mmEpix Orthopaedics Inc.3212-100112019-03-05
B2213212105111EPIX Lag Screw 105mm x 11mmEpix Orthopaedics Inc.3212-105112019-03-05
B2213212110111EPIX Lag Screw 110mm x 11mmEpix Orthopaedics Inc.3212-110112019-03-05
B2213212115111EPIX Lag Screw 115mm x 11mmEpix Orthopaedics Inc.3212-115112019-03-05
B2213212120111EPIX Lag Screw 120mm x 11mmEpix Orthopaedics Inc.3212-120112019-03-05
B2213310000001EPIX Anti-Rotation Cap 0.0mmEpix Orthopaedics Inc.3310-000002019-03-05
B2213310005001EPIX Anti-Rotation Cap 5.0mmEpix Orthopaedics Inc.3310-005002019-03-05
B2213310100001EPIX Anti-Rotation Cap 10.0mmEpix Orthopaedics Inc.3310-010002019-03-05
B2213310150001EPIX Anti-Rotation Cap 15.0mmEpix Orthopaedics Inc.3310-150002019-03-05
B2213315000001EPIX AntiRotation DeviceEpix Orthopaedics Inc.3315-000002019-03-05
B2219001025051EPIX Distal Screw 25.0mm x 5mmEpix Orthopaedics Inc.9001-025052019-03-05
B2219001027051EPIX Distal Screw 27.5mm x 5mmEpix Orthopaedics Inc.9001-027052019-03-05
B2219001030051EPIX Distal Screw 30.0mm x 5mmEpix Orthopaedics Inc.9001-030052019-03-05
B2219001032051EPIX Distal Screw 32.5mm x 5mmEpix Orthopaedics Inc.9001-032052019-03-05
B2219001035051EPIX Distal Screw 35.0mm x 5mmEpix Orthopaedics Inc.9001-035052019-03-05
B2219001037051EPIX Distal Screw 37.5mm x 5mmEpix Orthopaedics Inc.9001-037052019-03-05
B2219001040051EPIX Distal Screw 40.0mm x 5mmEpix Orthopaedics Inc.9001-040052019-03-05
B2219001042051EPIX Distal Screw 42.5mm x 5mmEpix Orthopaedics Inc.9001-042052019-03-05
B2219001045051EPIX Distal Screw 45.0mm x 5mmEpix Orthopaedics Inc.9001-045052019-03-05
B2219001050051EPIX Distal Screw 50.0mm x 5mmEpix Orthopaedics Inc.9001-050052019-03-05
B2219001055051EPIX Distal Screw 55.0mm x 5mmEpix Orthopaedics Inc.9001-055052019-03-05
B2219001060051EPIX Distal Screw 60.0mm x 5mmEpix Orthopaedics Inc.9001-060052019-03-05
B2219001065051EPIX Distal Screw 65.0mm x 5mmEpix Orthopaedics Inc.9001-065052019-03-05
B2219001070051EPIX Distal Screw 70.0mm x 5mmEpix Orthopaedics Inc.9001-070052019-03-05
B2219001075051EPIX Distal Screw 75.0mm x 5mmEpix Orthopaedics Inc.9001-075052019-03-05
B2219001080051EPIX Distal Screw 80.0mm x 5mmEpix Orthopaedics Inc.9001-080052019-03-05
B2219001085051EPIX Distal Screw 85.0mm x 5mmEpix Orthopaedics Inc.9001-085052019-03-05
B2219001090051EPIX Distal Screw 90.0mm x 5mmEpix Orthopaedics Inc.9001-090052019-03-05
B2219001100051EPIX Distal Screw 100.0mm x 5mmEpix Orthopaedics Inc.9001-100052019-03-05
B2219001110051EPIX Distal Screw 110.0mm x 5mmEpix Orthopaedics Inc.9001-110052019-03-05
B2219001120051EPIX Distal Screw 120.0mm x 5mmEpix Orthopaedics Inc.9001-120052019-03-05
07613252130604T2Stryker GmbH0194-1500S2015-09-24
07613252130611T2Stryker GmbH0194-2000S2015-09-24
07613252130628T2Stryker GmbH0194-2250S2015-09-24
07613252130635T2Stryker GmbH0194-2500S2015-09-24
07613252130642T2Stryker GmbH0194-1750S2015-09-24