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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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Pre-Lordosed Rod with Hex and Taper, 35mm
Orthofix US LLC
20-4035
In Commercial Distribution

  • 18257200009237 ()

  • Length: 35 Millimeter


  • Bone-screw internal spinal fixation system
Closed Body, Long
Orthofix US LLC
20-3120
In Commercial Distribution

  • 18257200009220 ()


  • Bone-screw internal spinal fixation system
Closed Body Standard
Orthofix US LLC
20-3090
In Commercial Distribution

  • 18257200009213 ()


  • Bone-screw internal spinal fixation system
Closed Body, Short
Orthofix US LLC
20-3070
In Commercial Distribution

  • 18257200009206 ()


  • Bone-screw internal spinal fixation system
Open Body, Long
Orthofix US LLC
20-2120
In Commercial Distribution

  • 18257200009190 ()


  • Bone-screw internal spinal fixation system
Open Body, Standard
Orthofix US LLC
20-2090
In Commercial Distribution

  • 18257200009183 ()


  • Bone-screw internal spinal fixation system
Open Body, Short
Orthofix US LLC
20-2070
In Commercial Distribution

  • 18257200009176 ()


  • Bone-screw internal spinal fixation system
8.5mm x 30mm Bone Screw, Self-Tapping, Cannulated
Orthofix US LLC
77-8830
In Commercial Distribution

  • 18257200021864 ()

  • Outer Diameter: 8.5 Millimeter
  • Length: 30 Millimeter


  • Bone-screw internal spinal fixation system
8.5mm x 25mm Bone Screw, Self-Tapping, Cannulated
Orthofix US LLC
77-8825
In Commercial Distribution

  • 18257200021840 ()

  • Length: 25 Millimeter
  • Outer Diameter: 8.5 Millimeter


  • Bone-screw internal spinal fixation system
8.5mm x 110mm Bone Screw, Self-Tapping, Cannulated
Orthofix US LLC
77-8811
In Commercial Distribution

  • 18257200021826 ()

  • Length: 110 Millimeter
  • Outer Diameter: 8.5 Millimeter


  • Bone-screw internal spinal fixation system
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