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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

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 - 10889981006969

Cannulated Dlta Polyaxial Screw, Diameter 7.5 x 80mm
SEASPINE ORTHOPEDICS CORPORATION
63-7580
In Commercial Distribution

  • 10889981006969 ()

  • Diameter 7.5 x 80mm
63-7580

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

UCR - 10889981000592

Polyaxial Reduction Screw 6.75 x 30 mm
SEASPINE ORTHOPEDICS CORPORATION
11-6730
In Commercial Distribution

  • 10889981000592 ()

  • 6.75 x 30 mm
11-6730

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

UCR - 10889981000585

Polyaxial Reduction Screw 6.0 x 60 mm
SEASPINE ORTHOPEDICS CORPORATION
11-6060
In Commercial Distribution

  • 10889981000585 ()

  • 6.0 x 60 mm
11-6060

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

UCR - 10889981000578

Polyaxial Reduction Screw 6.0 x 55 mm
SEASPINE ORTHOPEDICS CORPORATION
11-6055
In Commercial Distribution

  • 10889981000578 ()

  • 6.0 x 55 mm
11-6055

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

UCR - 10889981000561

Polyaxial Reduction Screw 6.0 x 50 mm
SEASPINE ORTHOPEDICS CORPORATION
11-6050
In Commercial Distribution

  • 10889981000561 ()

  • 6.0 x 50 mm
11-6050

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

UCR - 10889981000554

Polyaxial Reduction Screw 6.0 x 45 mm
SEASPINE ORTHOPEDICS CORPORATION
11-6045
In Commercial Distribution

  • 10889981000554 ()

  • 6.0 x 45 mm
11-6045

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