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, Solid, Ø5.5mm x 55mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730022228 ()
3PS55-55-01

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

  • 00815730022198 ()
3PS55-40-01

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

  • 00815730022174 ()
3PS55-30-01

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

  • 00815730022150 ()
3PS45-45-01

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

  • 00815730022136 ()
3PS45-35-01

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

  • 00815730022112 ()
3PS45-25-01

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

  • 00815730022099 ()
3PC55-25-01

  • Bone-screw internal spinal fixation system, non-sterile
Cross-Link, 5.5mm, Medium
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730022075 ()
5536-46-N

  • Trans-facet-screw internal spinal fixation system, 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 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 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 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 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 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 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 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 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 45mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021634 ()
3PC75-45-01

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw Assembly, Cannulated, Ø8.5mm x 30mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021429 ()
3PC85-30

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw Assembly, Cannulated, Ø7.5mm x 50mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021405 ()
3PC75-50

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw Assembly, Cannulated, Ø7.5mm x 35mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021375 ()
3PC75-35

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw Assembly, Cannulated, Ø7.5mm x 30mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021368 ()
3PC75-30

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw Assembly, Cannulated, Ø6.5mm x 50mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021344 ()
3PC65-50

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

  • 00815730021320 ()
3PC65-40

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

  • 00815730021283 ()
3PC55-50

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

  • 00815730021269 ()
3PC55-40

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

  • 00815730021245 ()
3PC55-30

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw Assembly, Reduction, Solid, Ø8.5mm x 110mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021238 ()
3PR85-110

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw Assembly, Reduction, Solid, Ø8.5mm x 100mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021221 ()
3PR85-100

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

  • 00815730021191 ()
3PR85-55

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw Assembly, Reduction, Solid, Ø8.5mm x 45mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021177 ()
3PR85-45

  • Bone-screw internal spinal fixation system, non-sterile
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
Poly-Axial Screw Assembly, Reduction, Solid, Ø8.5mm x 35mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021153 ()
3PR85-35

  • Bone-screw internal spinal fixation system, non-sterile
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
Poly-Axial Screw Assembly, Reduction Solid, Ø7.5mm x 120mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021139 ()
3PR75-120

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw Assembly, Reduction Solid, Ø7.5mm x 110mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021122 ()
3PR75-110

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw Assembly, Reduction Solid, Ø7.5mm x 100mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021115 ()
3PR75-100

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw Assembly, Reduction Solid, Ø7.5mm x 90mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021108 ()
3PR75-90

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw Assembly, Reduction Solid, Ø7.5mm x 80mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021092 ()
3PR75-80

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

  • 00815730021085 ()
3PR75-55

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

  • 00815730021078 ()
3PR75-50

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

  • 00815730021061 ()
3PR75-45

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

  • 00815730021054 ()
3PR75-40

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

  • 00815730021047 ()
3PR75-35

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

  • 00815730021030 ()
3PR75-30

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

  • 00815730021023 ()
3PR65-55

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