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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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NEO Modera Pedicle Screw System - 00815730021306

Poly-Axial Screw Assembly, Cannulated, Ø6.5mm x 30mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021306 ()
3PC65-30

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

NEO Modera Pedicle Screw System - 00815730020736

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

NEO Modera Pedicle Screw System - 00815730020712

Poly-Axial Screw Assembly, Solid, Ø5.5mm x 50mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730020712 ()
3PS55-50

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

NEO Modera Pedicle Screw System - 00815730020699

Poly-Axial Screw Assembly, Solid, Ø5.5mm x 40mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730020699 ()
3PS55-40

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

NEO Modera Pedicle Screw System - 00815730020668

Poly-Axial Screw Assembly, Solid, Ø4.5mm x 45mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730020668 ()
3PS45-45

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

NEO Modera Pedicle Screw System - 00815730020637

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

NEO Modera Pedicle Screw System - 00815730020613

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

NEO Modera Pedicle Screw System - 00815730020576

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

NEO Modera Pedicle Screw System - 00815730020552

Rod, Curved, Co-Cr, Ø5.5mm x 100mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730020552 ()
3RCC55-100

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

NEO Modera Pedicle Screw System - 00815730020521

Rod, Curved, Co-Cr, Ø5.5mm x 75mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730020521 ()
3RCC55-75

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