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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 - 10889981007218

Uni-Planar Screw, 5.5 DIA x 45mm
SEASPINE ORTHOPEDICS CORPORATION
67-5545
Not in Commercial Distribution

  • 10889981007218 ()

  • 5.5 DIA x 45mm
67-5545

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

Malibu - 10889981007201

Uni-Planar Screw, 5.5 DIA x 40mm
SEASPINE ORTHOPEDICS CORPORATION
67-5540
Not in Commercial Distribution

  • 10889981007201 ()

  • 5.5 DIA x 40mm
67-5540

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

Malibu - 10889981007195

Uni-Planar Screw, 5.5 DIA x 35mm
SEASPINE ORTHOPEDICS CORPORATION
67-5535
Not in Commercial Distribution

  • 10889981007195 ()

  • 5.5 DIA x 35mm
67-5535

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

Malibu - 10889981007188

Uni-Planar Screw, 5.5 DIAx 30mm
SEASPINE ORTHOPEDICS CORPORATION
67-5530
Not in Commercial Distribution

  • 10889981007188 ()

  • 5.5 DIAx 30mm
67-5530

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

Malibu - 10889981007171

Uni-Planar Screw, 5.5 DIA x 25mm
SEASPINE ORTHOPEDICS CORPORATION
67-5525
Not in Commercial Distribution

  • 10889981007171 ()

  • 5.5 DIA x 25mm
67-5525

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

Malibu - 10889981007164

Uni-Planar Screw, 5.0 DIA x 60mm
SEASPINE ORTHOPEDICS CORPORATION
67-5060
Not in Commercial Distribution

  • 10889981007164 ()

  • 5.0 DIA x 60mm
67-5060

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

Malibu - 10889981004736

Cannulated Polyaxial Screw, 8.5 x 75MM
SEASPINE ORTHOPEDICS CORPORATION
18-8575
Not in Commercial Distribution

  • 10889981004736 ()

  • 8.5 x 75MM
18-8575

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

Malibu - 10889981004712

Cannulated Polyaxial Screw, 8.5 x 65MM
SEASPINE ORTHOPEDICS CORPORATION
18-8565
Not in Commercial Distribution

  • 10889981004712 ()

  • 8.5 x 65MM
18-8565

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

Malibu - 10889981004682

Cannulated Polyaxial Screw, 8.5 x 50MM
SEASPINE ORTHOPEDICS CORPORATION
18-8550
Not in Commercial Distribution

  • 10889981004682 ()

  • 8.5 x 50MM
18-8550

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

Malibu - 10889981004675

Cannulated Polyaxial Screw, 8.5 x 45MM
SEASPINE ORTHOPEDICS CORPORATION
18-8545
Not in Commercial Distribution

  • 10889981004675 ()

  • 8.5 x 45MM
18-8545

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