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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 - 00815730020101

Rod, Straight, Titanium, Ø5.5mm x 70mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730020101 ()
3RST55-70

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

NEO Modera Pedicle Screw System - 00815730020095

Rod, Straight, Titanium, Ø5.5mm x 65mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730020095 ()
3RST55-65

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

NEO Modera Pedicle Screw System - 00815730020088

Rod, Straight, Titanium, Ø5.5mm x 60mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730020088 ()
3RST55-60

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

NEO Modera Pedicle Screw System - 00815730020071

Rod, Straight, Titanium, Ø5.5mm x 55mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730020071 ()
3RST55-55

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

NEO Modera Pedicle Screw System - 00815730020064

Rod, Straight, Titanium,Ø5.5mm x 50mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730020064 ()
3RST55-50

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

NEO Modera Pedicle Screw System - 00815730020057

Rod, Straight, Titanium,Ø5.5mm x 45mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730020057 ()
3RST55-45

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

NEO Modera Pedicle Screw System - 00815730020040

Rod, Straight, Titanium,Ø5.5mm x 40mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730020040 ()
3RST55-40

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

NEO Modera Pedicle Screw System - 00815730020033

Rod, Straight, Titanium, Ø5.5mm x 35mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730020033 ()
3RST55-35

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

NEO Modera Pedicle Screw System - 00815730020026

Rod, Straight, Titanium, Ø5.5mm x 30mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730020026 ()
3RST55-30

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

NEO Modera Pedicle Screw System - 00815730020019

Rod, Straight, Titanium, Ø5.5mm x 25mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730020019 ()
3RST55-25

  • Trans-facet-screw internal spinal fixation system, 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 - 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 - 00815730022525

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

NEO Modera Pedicle Screw System - 00815730022518

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

NEO Modera Pedicle Screw System - 00815730022501

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

NEO Modera Pedicle Screw System - 00815730022495

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

NEO Modera Pedicle Screw System - 00815730022488

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

NEO Modera Pedicle Screw System - 00815730022471

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

NEO Modera Pedicle Screw System - 00815730022464

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

NEO Modera Pedicle Screw System - 00815730022457

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

NEO Modera Pedicle Screw System - 00815730022440

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

NEO Modera Pedicle Screw System - 00815730022433

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

NEO Modera Pedicle Screw System - 00815730022426

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

NEO Modera Pedicle Screw System - 00815730022419

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

NEO Modera Pedicle Screw System - 00815730022402

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

NEO Modera Pedicle Screw System - 00815730022396

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

NEO Modera Pedicle Screw System - 00815730022389

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

NEO Modera Pedicle Screw System - 00815730022372

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

NEO Modera Pedicle Screw System - 00815730022365

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

NEO Modera Pedicle Screw System - 00815730022358

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

NEO Modera Pedicle Screw System - 00815730022341

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

NEO Modera Pedicle Screw System - 00815730022334

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

NEO Modera Pedicle Screw System - 00815730022327

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

NEO Modera Pedicle Screw System - 00815730022310

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

NEO Modera Pedicle Screw System - 00815730022303

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

NEO Modera Pedicle Screw System - 00815730022297

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

NEO Modera Pedicle Screw System - 00815730022280

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

NEO Modera Pedicle Screw System - 00815730022273

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

NEO Modera Pedicle Screw System - 00815730022266

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

NEO Modera Pedicle Screw System - 00815730022259

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

NEO Modera Pedicle Screw System - 00815730022242

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

NEO Modera Pedicle Screw System - 00815730022235

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

NEO Modera Pedicle Screw System - 00815730022228

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

NEO Modera Pedicle Screw System - 00815730022211

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

NEO Modera Pedicle Screw System - 00815730022204

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

NEO Modera Pedicle Screw System - 00815730022198

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

NEO Modera Pedicle Screw System - 00815730022174

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

NEO Modera Pedicle Screw System - 00815730022150

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

NEO Modera Pedicle Screw System - 00815730022129

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

  • 00815730022129 ()
3PS45-30-01

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

NEO Modera Pedicle Screw System - 00815730022112

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
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