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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 Type Device Class Implantable

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Malibu - 10381780012917

Malibu Polyaxial Reduction Screw,4.5 x 40mm
Seaspine, Inc.
13-4540
Not in Commercial Distribution

  • M5561345401 ()
  • 10381780012917 ()

  • 4.5 x 40mm
13-4540

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

Malibu - 10381780012894

Malibu Polyaxial Reduction Screw,4.5 x 30mm
Seaspine, Inc.
13-4530
Not in Commercial Distribution

  • M5561345301 ()
  • 10381780012894 ()

  • 4.5 x 30mm
13-4530

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

Malibu - 10381780012788

Malibu Polyaxial Screw, 8.5 x 40mm
Seaspine, Inc.
12-8540
Not in Commercial Distribution

  • M5561285401 ()
  • 10381780012788 ()

  • 8.5 x 40mm
12-8540

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

Malibu - 10381780012764

Malibu Polyaxial Screw, 8.5 x 30mm
Seaspine, Inc.
12-8530
Not in Commercial Distribution

  • M5561285301 ()
  • 10381780012764 ()

  • 8.5 x 30mm
12-8530

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

Malibu - 10381780012696

Malibu Polyaxial Screw,7.5 x 50mm
Seaspine, Inc.
12-7550
Not in Commercial Distribution

  • M5561275501 ()
  • 10381780012696 ()

  • 7.5 x 50mm
12-7550

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

Malibu - 10381780012689

Malibu Polyaxial Screw,7.5 x 45mm
Seaspine, Inc.
12-7545
Not in Commercial Distribution

  • M5561275451 ()
  • 10381780012689 ()

  • 7.5 x 45mm
12-7545

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

Malibu - 10381780012573

Malibu Polyaxial Screw,7.0 x 35mm
Seaspine, Inc.
12-7035
Not in Commercial Distribution

  • M5561270351 ()
  • 10381780012573 ()

  • 7.0 x 35mm
12-7035

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

Malibu - 10381780012566

Malibu Polyaxial Screw,7.0 x 30mm
Seaspine, Inc.
12-7030
Not in Commercial Distribution

  • M5561270301 ()
  • 10381780012566 ()

  • 7.0 x 30mm
12-7030

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

Malibu - 10381780012542

Malibu Polyaxial Screw,6.5 x 65mm
Seaspine, Inc.
12-6565
Not in Commercial Distribution

  • M5561265651 ()
  • 10381780012542 ()

  • 6.5 x 65mm
12-6565

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

Malibu - 10381780012313

Malibu Polyaxial Screw,4.5 x 50mm
Seaspine, Inc.
12-4550
Not in Commercial Distribution

  • M5561245501 ()
  • 10381780012313 ()

  • 4.5 x 50mm
12-4550

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