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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 - 10889981007034

Uni-Planar Screw, 4.5 DIA x 35mm
SEASPINE ORTHOPEDICS CORPORATION
67-4535
Not in Commercial Distribution

  • 10889981007034 ()

  • 4.5 DIA x 35mm
67-4535

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

Malibu - 10889981007027

Uni-Planar Screw, 4.5 DIA x 30mm
SEASPINE ORTHOPEDICS CORPORATION
67-4530
Not in Commercial Distribution

  • 10889981007027 ()

  • 4.5 DIA x 30mm
67-4530

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

Malibu - 10889981007010

Uni-Planar Screw, 4.5 DIA x 25mm
SEASPINE ORTHOPEDICS CORPORATION
67-4525
Not in Commercial Distribution

  • 10889981007010 ()

  • 4.5 DIA x 25mm
67-4525

  • 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 - 10889981006990

Cannulated Dlta Polyaxial Screw, Diameter 7.5 x 95mm
SEASPINE ORTHOPEDICS CORPORATION
63-7595
Not in Commercial Distribution

  • 10889981006990 ()

  • Diameter 7.5 x 95mm
63-7595

  • 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 - 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 - 10889981006914

Cannulated Dlta Polyaxial Screw, Diameter 7.5 x 55mm
SEASPINE ORTHOPEDICS CORPORATION
63-7555
Not in Commercial Distribution

  • 10889981006914 ()

  • Diameter 7.5 x 55mm
63-7555

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

NewPort - 10889981006884

Cannulated Dlta Polyaxial Screw, Diameter 7.5 x 40mm
SEASPINE ORTHOPEDICS CORPORATION
63-7540
In Commercial Distribution

  • 10889981006884 ()

  • Diameter 7.5 x 40mm
63-7540

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

NewPort - 10889981006877

Cannulated Dlta Polyaxial Screw, Diameter 7.5 x 35mm
SEASPINE ORTHOPEDICS CORPORATION
63-7535
In Commercial Distribution

  • 10889981006877 ()

  • Diameter 7.5 x 35mm
63-7535

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