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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, Ø6.5mm x 40mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730020750 ()
3PS65-40

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw Assembly, Solid, Ø6.5mm x 35mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730020743 ()
3PS65-35

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw Assembly, Solid, Ø6.5mm x 30mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730020736 ()
3PS65-30

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw Assembly, Cannulated, Ø5.5mm x 25mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730022556 ()
3PCS55-25

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw Assembly, Solid, Ø5.5mm x 25mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730022532 ()
3PS55-25

  • Bone-screw internal spinal fixation system, non-sterile
Modular Head Assembly, Reduction
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730022044 ()
3-MH-02

  • Trans-facet-screw internal spinal fixation system, sterile
Modular Head Assembly, Standard
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730022037 ()
3-MH-01

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw, Cannulated, Ø7.5mm x 55mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021658 ()
3PC75-55-01

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw, Cannulated, Ø7.5mm x 45mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021634 ()
3PC75-45-01

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw, Cannulated, Ø7.5mm x 40mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021627 ()
3PC75-40-01

  • Bone-screw internal spinal fixation system, non-sterile
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