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 Polyaxial Reduction Screw,6.5 x 35mm
Seaspine, Inc.
13-6535
Not in Commercial Distribution

  • M5561365351 ()
  • 10381780012986 ()

  • 6.5 x 35mm
13-6535

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,5.5 x 50mm
Seaspine, Inc.
13-5550
Not in Commercial Distribution

  • M5561355501 ()
  • 10381780012979 ()

  • 5.5 x 50mm
13-5550

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,5.5 x 45mm
Seaspine, Inc.
13-5545
Not in Commercial Distribution

  • M5561355451 ()
  • 10381780012962 ()

  • 5.5 x 45mm
13-5545

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,5.5 x 40mm
Seaspine, Inc.
13-5540
Not in Commercial Distribution

  • M5561355401 ()
  • 10381780012955 ()

  • 5.5 x 40mm
13-5540

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,5.5 x 35mm
Seaspine, Inc.
13-5535
Not in Commercial Distribution

  • M5561355351 ()
  • 10381780012948 ()

  • 5.5 x 35mm
13-5535

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,5.5 x 30mm
Seaspine, Inc.
13-5530
Not in Commercial Distribution

  • M5561355301 ()
  • 10381780012931 ()

  • 5.5 x 30mm
13-5530

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,5.5 x 25mm
Seaspine, Inc.
13-5525
Not in Commercial Distribution

  • M5561355251 ()
  • 10381780012924 ()

  • 5.5 x 25mm
13-5525

  • Bone-screw internal spinal fixation system, non-sterile
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 Polyaxial Reduction Screw,4.5 x 35mm
Seaspine, Inc.
13-4535
Not in Commercial Distribution

  • M5561345351 ()
  • 10381780012900 ()

  • 4.5 x 35mm
13-4535

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