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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 - 10889981007348

Uni-Planar Screw, 6.5 DIA x 105mm
SEASPINE ORTHOPEDICS CORPORATION
67-6505
Not in Commercial Distribution

  • 10889981007348 ()

  • 6.5 DIA x 105mm
67-6505

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

Malibu - 10889981007324

Uni-Planar Screw, 6.0 DIA x 60mm
SEASPINE ORTHOPEDICS CORPORATION
67-6060
Not in Commercial Distribution

  • 10889981007324 ()

  • 6.0 DIA x 60mm
67-6060

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

Malibu - 10889981007317

Uni-Planar Screw, 6.0 DIA x 55mm
SEASPINE ORTHOPEDICS CORPORATION
67-6055
Not in Commercial Distribution

  • 10889981007317 ()

  • 6.0 DIA x 55mm
67-6055

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

Malibu - 10889981007294

Uni-Planar Screw, 6.0 DIA x 45mm
SEASPINE ORTHOPEDICS CORPORATION
67-6045
Not in Commercial Distribution

  • 10889981007294 ()

  • 6.0 DIA x 45mm
67-6045

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

Malibu - 10889981007263

Uni-Planar Screw, 6.0 DIA x 30mm
SEASPINE ORTHOPEDICS CORPORATION
67-6030
Not in Commercial Distribution

  • 10889981007263 ()

  • 6.0 DIA x 30mm
67-6030

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

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

NewPort - 10889981006983

Cannulated Dlta Polyaxial Screw, Diameter 7.5 x 90mm
SEASPINE ORTHOPEDICS CORPORATION
63-7590
Not in Commercial Distribution

  • 10889981006983 ()

  • Diameter 7.5 x 90mm
63-7590

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

NewPort - 10889981006976

Cannulated Dlta Polyaxial Screw, Diameter 7.5 x 85mm
SEASPINE ORTHOPEDICS CORPORATION
63-7585
Not in Commercial Distribution

  • 10889981006976 ()

  • Diameter 7.5 x 85mm
63-7585

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

NewPort - 10889981006952

Cannulated Dlta Polyaxial Screw, Diameter 7.5 x 75mm
SEASPINE ORTHOPEDICS CORPORATION
63-7575
Not in Commercial Distribution

  • 10889981006952 ()

  • Diameter 7.5 x 75mm
63-7575

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

NewPort - 10889981006945

Cannulated Dlta Polyaxial Screw, Diameter 7.5 x 70mm
SEASPINE ORTHOPEDICS CORPORATION
63-7570
In Commercial Distribution

  • 10889981006945 ()

  • Diameter 7.5 x 70mm
63-7570

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