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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Mono-Axial Screw, Solid, Ø8.5mm x 30mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730021962 ()
3MS85-30

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

  • 00815730021955 ()
3MS75-55

  • Bone-screw internal spinal fixation system, non-sterile
Mono-Axial Screw, Solid, Ø7.5mm x 50mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730021948 ()
3MS75-50

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

  • 00815730021931 ()
3MS75-45

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

  • 00815730021924 ()
3MS75-40

  • Bone-screw internal spinal fixation system, non-sterile
Mono-Axial Screw, Solid, Ø7.5mm x 35mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730021917 ()
3MS75-35

  • Bone-screw internal spinal fixation system, non-sterile
Mono-Axial Screw, Solid, Ø7.5mm x 30mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730021900 ()
3MS75-30

  • Bone-screw internal spinal fixation system, non-sterile
Mono-Axial Screw, Solid, Ø6.5mm x 55mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730021894 ()
3MS65-55

  • Bone-screw internal spinal fixation system, non-sterile
Mono-Axial Screw, Solid, Ø6.5mm x 50mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730021887 ()
3MS65-50

  • Bone-screw internal spinal fixation system, non-sterile
Mono-Axial Screw, Solid, Ø6.5mm x 45mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730021870 ()
3MS65-45

  • Bone-screw internal spinal fixation system, non-sterile
Mono-Axial Screw, Solid, Ø6.5mm x 40mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730021863 ()
3MS65-40

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

  • 00815730021856 ()
3MS65-35

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

  • 00815730021849 ()
3MS65-30

  • Bone-screw internal spinal fixation system, non-sterile
Mono-Axial Screw, Solid, Ø5.5mm x 55mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730021832 ()
3MS55-55

  • Bone-screw internal spinal fixation system, non-sterile
Mono-Axial Screw, Solid, Ø5.5mm x 50mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730021825 ()
3MS55-50

  • Bone-screw internal spinal fixation system, non-sterile
Mono-Axial Screw, Solid, Ø5.5mm x 45mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730021818 ()
3MS55-45

  • Bone-screw internal spinal fixation system, non-sterile
Mono-Axial Screw, Solid, Ø5.5mm x 40mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730021801 ()
3MS55-40

  • Bone-screw internal spinal fixation system, non-sterile
Mono-Axial Screw, Solid, Ø5.5mm x 35mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730021795 ()
3MS55-35

  • Bone-screw internal spinal fixation system, non-sterile
Mono-Axial Screw, Solid, Ø5.5mm x 30mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730021788 ()
3MS55-30

  • Bone-screw internal spinal fixation system, non-sterile
Mono-Axial Screw, Solid, Ø4.5mm x 45mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730021771 ()
3MS45-45

  • Bone-screw internal spinal fixation system, non-sterile
Mono-Axial Screw, Solid, Ø4.5mm x 40mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730021764 ()
3MS45-40

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

  • 00815730021757 ()
3MS45-35

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

  • 00815730021740 ()
3MS45-30

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

  • 00815730021733 ()
3MS45-25

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

  • 00815730021726 ()
3MS45-20

  • Bone-screw internal spinal fixation system, non-sterile
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
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
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
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
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
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
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 50mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021641 ()
3PC75-50-01

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

  • 00815730021580 ()
3PC65-50-01

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw, Cannulated, Ø6.5mm x 45mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021573 ()
3PC65-45-01

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw, Cannulated, Ø6.5mm x 40mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021566 ()
3PC65-40-01

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

  • 00815730021559 ()
3PC65-35-01

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

  • 00815730021542 ()
3PC65-30-01

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw, Cannulated, Ø5.5mm x 55mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021535 ()
3PC55-55-01

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw, Cannulated, Ø5.5mm x 50mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021528 ()
3PC55-50-01

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw, Cannulated, Ø5.5mm x 45mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021511 ()
3PC55-45-01

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw, Cannulated, Ø5.5mm x 40mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021504 ()
3PC55-40-01

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw, Cannulated, Ø5.5mm x 35mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021498 ()
3PC55-35-01

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw, Cannulated, Ø5.5mm x 30mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021481 ()
3PC55-30-01

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw Assembly, Cannulated, Ø8.5mm x 55mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021474 ()
3PC85-55

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