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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 - 10889981007003

Uni-Planar Screw, 4.5 DIA x 20mm
SEASPINE ORTHOPEDICS CORPORATION
67-4520
Not in Commercial Distribution

  • 10889981007003 ()

  • 4.5 DIA x 20mm
67-4520

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

Malibu - 10889981004729

Cannulated Polyaxial Screw, 8.5 x 70MM
SEASPINE ORTHOPEDICS CORPORATION
18-8570
Not in Commercial Distribution

  • 10889981004729 ()

  • 8.5 x 70MM
18-8570

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

Malibu - 10889981004699

Cannulated Polyaxial Screw, 8.5 x 55MM
SEASPINE ORTHOPEDICS CORPORATION
18-8555
Not in Commercial Distribution

  • 10889981004699 ()

  • 8.5 x 55MM
18-8555

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

Malibu - 10889981004668

Cannulated Polyaxial Screw, 8.5 x 40MM
SEASPINE ORTHOPEDICS CORPORATION
18-8540
Not in Commercial Distribution

  • 10889981004668 ()

  • 8.5 x 40MM
18-8540

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

Malibu - 10889981004644

Cannulated Polyaxial Screw, 8.5 x 30MM
SEASPINE ORTHOPEDICS CORPORATION
18-8530
Not in Commercial Distribution

  • 10889981004644 ()

  • 8.5 x 30MM
18-8530

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

Malibu - 10889981004637

Cannulated Polyaxial Screw, 8.0 x 80MM
SEASPINE ORTHOPEDICS CORPORATION
18-8080
Not in Commercial Distribution

  • 10889981004637 ()

  • 8.0 x 80MM
18-8080

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

Malibu - 10889981004620

Cannulated Polyaxial Screw, 8.0 x 75MM
SEASPINE ORTHOPEDICS CORPORATION
18-8075
Not in Commercial Distribution

  • 10889981004620 ()

  • 8.0 x 75MM
18-8075

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

Malibu - 10889981004606

Cannulated Polyaxial Screw, 8.0 x 65MM
SEASPINE ORTHOPEDICS CORPORATION
18-8065
Not in Commercial Distribution

  • 10889981004606 ()

  • 8.0 x 65MM
18-8065

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

Malibu - 10889981004576

Cannulated Polyaxial Screw, 8.0 x 50MM
SEASPINE ORTHOPEDICS CORPORATION
18-8050
Not in Commercial Distribution

  • 10889981004576 ()

  • 8.0 x 50MM
18-8050

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

Malibu - 10889981004552

Cannulated Polyaxial Screw, 8.0 x 40MM
SEASPINE ORTHOPEDICS CORPORATION
18-8040
Not in Commercial Distribution

  • 10889981004552 ()

  • 8.0 x 40MM
18-8040

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