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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 - 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 - 00815730022181

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

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 - 00815730022167

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

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 - 00815730022143

Poly-Axial Screw, Solid, Ø4.5mm x 40mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730022143 ()
3PS45-40-01

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

NEO Modera Pedicle Screw System - 00815730022136

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

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

NEO Modera Pedicle Screw System - 00815730022105

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

  • 00815730022105 ()
3PS45-20-01

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

NEO Modera Pedicle Screw System - 00815730022099

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

NEO Modera Pedicle Screw System - 00815730022082

Cross-Link, 5.5mm, Large
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730022082 ()
5546-66-N

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

NEO Modera Pedicle Screw System - 00815730022075

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

NEO Modera Pedicle Screw System - 00815730022068

Cross-Link, 5.5mm,Small
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730022068 ()
5531-36-N

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

NEO Modera Pedicle Screw System - 00815730022051

Cross-Link, 5.5mm, Extra-Small
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730022051 ()
5528-31-N

  • Trans-facet-screw internal spinal fixation system, 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 - 00815730022020

Locking Cap (Set Screw)
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730022020 ()
3LC-01

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

NEO Modera Pedicle Screw System - 00815730022013

Mono-Axial Screw, Solid, Ø8.5mm x 55mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730022013 ()
3MS85-55

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

NEO Modera Pedicle Screw System - 00815730022006

Mono-Axial Screw, Solid, Ø8.5mm x 50mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730022006 ()
3MS85-50

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

NEO Modera Pedicle Screw System - 00815730021993

Mono-Axial Screw, Solid, Ø8.5mm x 45mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730021993 ()
3MS85-45

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

NEO Modera Pedicle Screw System - 00815730021986

Mono-Axial Screw, Solid, Ø8.5mm x 40mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730021986 ()
3MS85-40

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

NEO Modera Pedicle Screw System - 00815730021979

Mono-Axial Screw, Solid, Ø8.5mm x 35mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730021979 ()
3MS85-35

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

NEO Modera Pedicle Screw System - 00815730021962

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

NEO Modera Pedicle Screw System - 00815730021955

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
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