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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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5.5mm x 25mm Mono Axial Screw, Self-Tapping
Orthofix US LLC
44-7525
In Commercial Distribution

  • 18257200012398 ()

  • Length: 25 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system
5.5mm x 110mm Mono-Axial Screw, Self-Tapping
Orthofix US LLC
44-7511
In Commercial Distribution

  • 18257200012381 ()

  • Length: 110 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system
5.5mm x 100mm Mono-Axial Screw, Self-Tapping
Orthofix US LLC
44-7510
In Commercial Distribution

  • 18257200012374 ()

  • Length: 100 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system
4.5mm x 95mm Mono-Axial Screw, Self-Tapping
Orthofix US LLC
44-7495
In Commercial Distribution

  • 18257200012367 ()

  • Length: 95 Millimeter
  • Outer Diameter: 4.5 Millimeter


  • Bone-screw internal spinal fixation system
4.5mm x 90mm Mono Axial Screw, Self-Tapping
Orthofix US LLC
44-7490
In Commercial Distribution

  • 18257200012350 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 90 Millimeter


  • Bone-screw internal spinal fixation system
4.5mm x 85mm Mono-Axial Screw, Self-Tapping
Orthofix US LLC
44-7485
In Commercial Distribution

  • 18257200012343 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 85 Millimeter


  • Bone-screw internal spinal fixation system
4.5mm x 80mm Mono-Axial Screw, Self-Tapping
Orthofix US LLC
44-7480
In Commercial Distribution

  • 18257200012336 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 80 Millimeter


  • Bone-screw internal spinal fixation system
4.5mm x 75mm Mono-Axial Screw, Self-Tapping
Orthofix US LLC
44-7475
In Commercial Distribution

  • 18257200012329 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 75 Millimeter


  • Bone-screw internal spinal fixation system
4.5mm x 70mm Mono-Axial Screw, Self-Tapping
Orthofix US LLC
44-7470
In Commercial Distribution

  • 18257200012312 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 70 Millimeter


  • Bone-screw internal spinal fixation system
4.5mm x 65mm Mono-Axial Screw, Self-Tapping
Orthofix US LLC
44-7465
In Commercial Distribution

  • 18257200012305 ()

  • Length: 65 Millimeter
  • Outer Diameter: 4.5 Millimeter


  • Bone-screw internal spinal fixation system
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