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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 Class Implantable

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5.5mm x 25mm Uniplanar Screw, Self-Tapping
Orthofix US LLC
51-3525
In Commercial Distribution

  • 18257200014682 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 25 Millimeter


  • Bone-screw internal spinal fixation system
4.5mm x 45mm Uniplanar Screw, Self-Tapping
Orthofix US LLC
51-3445
In Commercial Distribution

  • 18257200014675 ()

  • Length: 45 Millimeter
  • Outer Diameter: 4.5 Millimeter


  • Bone-screw internal spinal fixation system
4.5mm x 35mm Uniplanar Screw, Self-Tapping
Orthofix US LLC
51-3435
In Commercial Distribution

  • 18257200014651 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 35 Millimeter


  • Bone-screw internal spinal fixation system
4.0mm x 45mm Uniplanar Screw, Self-Tapping
Orthofix US LLC
51-3345
In Commercial Distribution

  • 18257200014521 ()

  • Outer Diameter: 4.0 Millimeter
  • Length: 45 Millimeter


  • Bone-screw internal spinal fixation system
4.0mm x 35mm Uniplanar Screw, Self-Tapping
Orthofix US LLC
51-3335
In Commercial Distribution

  • 18257200014507 ()

  • Length: 35 Millimeter
  • Outer Diameter: 4.0 Millimeter


  • Bone-screw internal spinal fixation system
8.5mm x 95mm Mono-Axial Screw, Self-Tapping
Orthofix US LLC
44-7895
In Commercial Distribution

  • 18257200013043 ()

  • Outer Diameter: 8.5 Millimeter
  • Length: 95 Millimeter


  • Bone-screw internal spinal fixation system
8.5mm x 90mm Mono-Axial Screw, Self-Tapping
Orthofix US LLC
44-7890
In Commercial Distribution

  • 18257200013036 ()

  • Length: 90 Millimeter
  • Outer Diameter: 8.5 Millimeter


  • Bone-screw internal spinal fixation system
8.5mm x 85mm Mono-Axial Screw, Self-Tapping
Orthofix US LLC
44-7885
In Commercial Distribution

  • 18257200013029 ()

  • Length: 85 Millimeter
  • Outer Diameter: 8.5 Millimeter


  • Bone-screw internal spinal fixation system
8.5mm x 80mm Mono-Axial Screw, Self-Tapping
Orthofix US LLC
44-7880
In Commercial Distribution

  • 18257200013012 ()

  • Outer Diameter: 8.5 Millimeter
  • Length: 80 Millimeter


  • Bone-screw internal spinal fixation system
8.5mm x 75mm Mono-Axial Screw, Self-Tapping
Orthofix US LLC
44-7875
In Commercial Distribution

  • 18257200013005 ()

  • Outer Diameter: 8.5 Millimeter
  • Length: 75 Millimeter


  • Bone-screw internal spinal fixation system
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