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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 - 00815730021214

Poly-Axial Screw Assembly, Reduction, Solid, Ø8.5mm x 90mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021214 ()
3PR85-90

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

NEO Modera Pedicle Screw System - 00815730021207

Poly-Axial Screw Assembly, Reduction, Solid, Ø8.5mm x 80mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021207 ()
3PR85-80

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

NEO Modera Pedicle Screw System - 00815730021184

Poly-Axial Screw Assembly, Reduction, Solid, Ø8.5mm x 50mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021184 ()
3PR85-50

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

NEO Modera Pedicle Screw System - 00815730021160

Poly-Axial Screw Assembly, Reduction, Solid, Ø8.5mm x 40mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021160 ()
3PR85-40

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

NEO Modera Pedicle Screw System - 00815730021146

Poly-Axial Screw Assembly, Reduction, Solid, Ø8.5mm x 30mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021146 ()
3PR85-30

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

NEO Modera Pedicle Screw System - 00815730020873

Poly-Axial Screw Assembly, Reduction, Solid, Ø4.5mm x 30mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730020873 ()
3PR45-30

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

NEO Modera Pedicle Screw System - 00815730020866

Poly-Axial Screw Assembly, Reduction, Solid, Ø4.5mm x 25mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730020866 ()
3PR45-25

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

NEO Modera Pedicle Screw System - 00815730020859

Poly-Axial Screw Assembly, Reduction, Solid, Ø4.5mm x 20mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730020859 ()
3PR45-20

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

NEO Modera Pedicle Screw System - 00815730020842

Poly-Axial Screw, Solid, Ø7.5mm x 55mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730020842 ()
3PS75-55

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

NEO Modera Pedicle Screw System - 00815730020835

Poly-Axial Screw Assembly, Solid, Ø7.5mm x 50mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730020835 ()
3PS75-50

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

NEO Modera Pedicle Screw System - 00815730020828

Poly-Axial Screw Assembly, Solid, Ø7.5mm x 45mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730020828 ()
3PS75-45

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

NEO Modera Pedicle Screw System - 00815730020811

Poly-Axial Screw Assembly, Solid, Ø7.5mm x 40mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730020811 ()
3PS75-40

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

NEO Modera Pedicle Screw System - 00815730020804

Poly-Axial Screw Assembly, Solid, Ø7.5mm x 35mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730020804 ()
3PS75-35

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

NEO Modera Pedicle Screw System - 00815730020798

Poly-Axial Screw Assembly, Solid, Ø7.5mm x 30mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730020798 ()
3PS75-30

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

NEO Modera Pedicle Screw System - 00815730020781

Poly-Axial Screw Assembly, Solid, Ø6.5mm x 55mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730020781 ()
3PS65-55

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

NEO Modera Pedicle Screw System - 00815730020774

Poly-Axial Screw Assembly, Solid, Ø6.5mm x 50mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730020774 ()
3PS65-50

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

NEO Modera Pedicle Screw System - 00815730020767

Poly-Axial Screw Assembly, Solid, Ø6.5mm x 45mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730020767 ()
3PS65-45

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

NEO Modera Pedicle Screw System - 00815730020750

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

NEO Modera Pedicle Screw System - 00815730020743

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

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 - 00815730020729

Poly-Axial Screw Assembly, Solid, Ø5.5mm x 55mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730020729 ()
3PS55-55

  • 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 - 00815730020705

Poly-Axial Screw Assembly, Solid, Ø5.5mm x 45mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730020705 ()
3PS55-45

  • 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 - 00815730020682

Poly-Axial Screw Assembly, Solid, Ø5.5mm x 35mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730020682 ()
3PS55-35

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

NEO Modera Pedicle Screw System - 00815730020675

Poly-Axial Screw Assembly, Solid, Ø5.5mm x 30mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730020675 ()
3PS55-30

  • 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 - 00815730020651

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

NEO Modera Pedicle Screw System - 00815730020644

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

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 - 00815730020620

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

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 - 00815730022556

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

NEO Modera Pedicle Screw System - 00815730022549

Poly-Axial Screw Assembly, Reduction, Solid, Ø5.5mm x 25mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730022549 ()
3PR55-25

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

NEO Modera Pedicle Screw System - 00815730022532

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

NEO Modera Pedicle Screw System - 00815730022044

Modular Head Assembly, Reduction
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730022044 ()
3-MH-02

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

NEO Modera Pedicle Screw System - 00815730022037

Modular Head Assembly, Standard
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730022037 ()
3-MH-01

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

NEO Modera Pedicle Screw System - 00815730021719

Poly-Axial Screw, Cannulated, Ø8.5mm x 55mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021719 ()
3PC85-55-01

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

NEO Modera Pedicle Screw System - 00815730021702

Poly-Axial Screw, Cannulated Ø8.5mm x 50mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021702 ()
3PC85-50-01

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

NEO Modera Pedicle Screw System - 00815730021696

Poly-Axial Screw, Cannulated, Ø8.5mm x 45mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021696 ()
3PC85-45-01

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

NEO Modera Pedicle Screw System - 00815730021689

Poly-Axial Screw, Cannulated, Ø8.5mm x 40mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021689 ()
3PC85-40-01

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

NEO Modera Pedicle Screw System - 00815730021672

Poly-Axial Screw, Cannulated, Ø8.5mm x 35mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021672 ()
3PC85-35-01

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

NEO Modera Pedicle Screw System - 00815730021665

Poly-Axial Screw, Cannulated, Ø8.5mm x 30mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021665 ()
3PC85-30-01

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

NEO Modera Pedicle Screw System - 00815730021658

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

NEO Modera Pedicle Screw System - 00815730021641

Poly-Axial Screw, Cannulated, Ø7.5mm x 50mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021641 ()
3PC75-50-01

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

NEO Modera Pedicle Screw System - 00815730021634

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

NEO Modera Pedicle Screw System - 00815730021627

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

NEO Modera Pedicle Screw System - 00815730021610

Poly-Axial Screw, Cannulated, Ø7.5mm x 35mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021610 ()
3PC75-35-01

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

NEO Modera Pedicle Screw System - 00815730021603

Poly-Axial Screw, Cannulated, Ø7.5mm x 30mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021603 ()
3PC75-30-01

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

NEO Modera Pedicle Screw System - 00815730021597

Poly-Axial Screw, Cannulated, Ø6.5mm x 55mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021597 ()
3PC65-55-01

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