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, 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, 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
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
Rod, Curved, Titanium, Ø5.5mm x 110mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730022525 ()
3RTC55-110

  • Trans-facet-screw internal spinal fixation system, sterile
Rod, Straight, Titanium, Ø5.5mm x 110mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730022518 ()
3RTS55-110

  • Trans-facet-screw internal spinal fixation system, sterile
Poly-Axial Screw, Solid, Ø8.5mm x 90mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730022501 ()
3PS85-90-01

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw, Solid, Ø8.5mm x 80mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730022495 ()
3PS85-80-01

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

  • 00815730022488 ()
3PS85-55-01

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw, Solid, Ø8.5mm x 50mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730022471 ()
3PS85-50-01

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

  • 00815730022464 ()
3PS85-45-01

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw, Solid, Ø8.5mm x 40mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730022457 ()
3PS85-40-01

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

  • 00815730022440 ()
3PS85-35-01

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

  • 00815730022433 ()
3PS85-30-01

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw, Solid, Ø8.5mm x 120mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730022426 ()
3PS85-120-01

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

  • 00815730022419 ()
3PS85-110-01

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

  • 00815730022402 ()
3PS85-100-01

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

  • 00815730022396 ()
3PS75-90-01

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

  • 00815730022389 ()
3PS75-80-01

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

  • 00815730022372 ()
3PS75-55-01

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

  • 00815730022365 ()
3PS75-50-01

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

  • 00815730022358 ()
3PS75-45-01

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

  • 00815730022341 ()
3PS75-40-01

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

  • 00815730022334 ()
3PS75-35-01

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

  • 00815730022327 ()
3PS75-30-01

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

  • 00815730022310 ()
3PS75-120-01

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

  • 00815730022303 ()
3PS75-110-01

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

  • 00815730022297 ()
3PS75-100-01

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

  • 00815730022280 ()
3PS65-55-01

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

  • 00815730022273 ()
3PS65-50-01

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

  • 00815730022266 ()
3PS65-45-01

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

  • 00815730022259 ()
3PS65-40-01

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

  • 00815730022242 ()
3PS65-35-01

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

  • 00815730022235 ()
3PS65-30-01

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

  • 00815730022211 ()
3PS55-50-01

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

  • 00815730022204 ()
3PS55-45-01

  • 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 35mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730022181 ()
3PS55-35-01

  • 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, Ø5.5mm x 25mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730022167 ()
3PS55-25-01

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