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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 - 10889981008079

Uni-Planar Reduction Screw, 6.5 DIA x 105mm
SEASPINE ORTHOPEDICS CORPORATION
68-6505
Not in Commercial Distribution

  • 10889981008079 ()

  • 6.5 DIA x 105mm
68-6505

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

Malibu - 10889981008062

Uni-Planar Reduction Screw, 6.5 DIA x 100mm
SEASPINE ORTHOPEDICS CORPORATION
68-6500
Not in Commercial Distribution

  • 10889981008062 ()

  • 6.5 DIA x 100mm
68-6500

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

Malibu - 10889981007591

Uni-Planar Screw, 7.0 DIA x 65mm
SEASPINE ORTHOPEDICS CORPORATION
67-7065
Not in Commercial Distribution

  • 10889981007591 ()

  • 7.0 DIA x 65mm
67-7065

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

Malibu - 10889981007584

Uni-Planar Screw, 7.0 DIA x 60mm
SEASPINE ORTHOPEDICS CORPORATION
67-7060
Not in Commercial Distribution

  • 10889981007584 ()

  • 7.0 DIA x 60mm
67-7060

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

Malibu - 10889981007560

Uni-Planar Screw, 7.0 DIA x 50mm
SEASPINE ORTHOPEDICS CORPORATION
67-7050
Not in Commercial Distribution

  • 10889981007560 ()

  • 7.0 DIA x 50mm
67-7050

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

Malibu - 10889981007515

Uni-Planar Screw, 7.0 DIA x 25mm
SEASPINE ORTHOPEDICS CORPORATION
67-7025
Not in Commercial Distribution

  • 10889981007515 ()

  • 7.0 DIA x 25mm
67-7025

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

Malibu - 10889981007508

Uni-Planar Screw, 6.5 DIA x 95mm
SEASPINE ORTHOPEDICS CORPORATION
67-6595
Not in Commercial Distribution

  • 10889981007508 ()

  • 6.5 DIA x 95mm
67-6595

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

Malibu - 10889981007492

Uni-Planar Screw, 6.5 DIA x 90mm
SEASPINE ORTHOPEDICS CORPORATION
67-6590
Not in Commercial Distribution

  • 10889981007492 ()

  • 6.5 DIA x 90mm
67-6590

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

Malibu - 10889981007485

Uni-Planar Screw, 6.5 DIA x 85mm
SEASPINE ORTHOPEDICS CORPORATION
67-6585
Not in Commercial Distribution

  • 10889981007485 ()

  • 6.5 DIA x 85mm
67-6585

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

Malibu - 10889981007478

Uni-Planar Screw, 6.5 DIA x 80mm
SEASPINE ORTHOPEDICS CORPORATION
67-6580
Not in Commercial Distribution

  • 10889981007478 ()

  • 6.5 DIA x 80mm
67-6580

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