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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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Poly-Axial Screw Assembly, Solid, Ø4.5mm x 40mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730020651 ()
3PS45-40

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw Assembly, Solid, Ø4.5mm x 35mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730020644 ()
3PS45-35

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw Assembly, Solid, Ø4.5mm x 30mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730020637 ()
3PS45-30

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw Assembly, Solid, Ø4.5mm x 25mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730020620 ()
3PS45-25

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw Assembly, Solid, Ø4.5mm x 20mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730020613 ()
3PS45-20

  • Bone-screw internal spinal fixation system, non-sterile
Rod, Curved, Co-Cr, Ø5.5mm x 150mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730020606 ()
3RCC55-150

  • Trans-facet-screw internal spinal fixation system, sterile
Rod, Curved, Co-Cr, Ø5.5mm x 140mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730020590 ()
3RCC55-140

  • Trans-facet-screw internal spinal fixation system, sterile
Rod, Curved, Co-Cr, Ø5.5mm x 130mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730020583 ()
3RCC55-130

  • Trans-facet-screw internal spinal fixation system, sterile
Rod, Curved, Co-Cr, Ø5.5mm x 120mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730020576 ()
3RCC55-120

  • Trans-facet-screw internal spinal fixation system, sterile
Rod, Curved, Co-Cr, Ø5.5mm x 110mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730020569 ()
3RCC55-110

  • Trans-facet-screw internal spinal fixation system, sterile
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