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,8.0 x 55mm
Seaspine, Inc.
13-8055
Not in Commercial Distribution

  • M5561380551 ()
  • 10381780002130 ()

  • 8.0 x 55mm
13-8055

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,8.0 x 50mm
Seaspine, Inc.
13-8050
Not in Commercial Distribution

  • M5561380501 ()
  • 10381780002123 ()

  • 8.0 x 50mm
13-8050

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,8.0 x 45mm
Seaspine, Inc.
13-8045
Not in Commercial Distribution

  • M5561380451 ()
  • 10381780002116 ()

  • 8.0 x 45mm
13-8045

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,8.0 x 40mm
Seaspine, Inc.
13-8040
Not in Commercial Distribution

  • M5561380401 ()
  • 10381780002109 ()

  • 8.0 x 40mm
13-8040

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,8.0 x 35mm
Seaspine, Inc.
13-8035
Not in Commercial Distribution

  • M5561380351 ()
  • 10381780002093 ()

  • 8.0 x 35mm
13-8035

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,8.0 x 30mm
Seaspine, Inc.
13-8030
Not in Commercial Distribution

  • M5561380301 ()
  • 10381780002086 ()

  • 8.0 x 30mm
13-8030

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,8.0 x 110mm
Seaspine, Inc.
13-8010
Not in Commercial Distribution

  • M5561380101 ()
  • 10381780002079 ()

  • 8.0 x 110mm
13-8010

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,8.0 x 105mm
Seaspine, Inc.
13-8005
Not in Commercial Distribution

  • M5561380051 ()
  • 10381780002062 ()

  • 8.0 x 105mm
13-8005

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,8.0 x 100mm
Seaspine, Inc.
13-8000
Not in Commercial Distribution

  • M5561380001 ()
  • 10381780002055 ()

  • 8.0 x 100mm
13-8000

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,7.5 x 95mm
Seaspine, Inc.
13-7595
Not in Commercial Distribution

  • M5561375951 ()
  • 10381780002048 ()

  • 7.5 x 95mm
13-7595

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