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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 - 10381780005018

Uni-Planar Screw, 4.5 DIA x 35mm
Seaspine, Inc.
67-4535
Not in Commercial Distribution

  • M5566745351 ()
  • 10381780005018 ()

  • 4.5 DIA x 35mm
67-4535

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

Malibu - 10381780005001

Uni-Planar Screw, 4.5 DIA x 30mm
Seaspine, Inc.
67-4530
Not in Commercial Distribution

  • M5566745301 ()
  • 10381780005001 ()

  • 4.5 DIA x 30mm
67-4530

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

Malibu - 10381780004998

Uni-Planar Screw, 4.5 DIA x 25mm
Seaspine, Inc.
67-4525
Not in Commercial Distribution

  • M5566745251 ()
  • 10381780004998 ()

  • 4.5 DIA x 25mm
67-4525

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

Malibu - 10381780004981

Uni-Planar Screw, 4.5 DIA x 20mm
Seaspine, Inc.
67-4520
Not in Commercial Distribution

  • M5566745201 ()
  • 10381780004981 ()

  • 4.5 DIA x 20mm
67-4520

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

Malibu - 10889981082062

Trial Rod, 4.8x600mm
SEASPINE ORTHOPEDICS CORPORATION
91-2984
In Commercial Distribution

  • 10889981082062 ()

  • 4.8x600mm
91-2984

  • Spinal implant trial

Malibu - 10889981082055

Trial Rod, 4.8 x 250mm
SEASPINE ORTHOPEDICS CORPORATION
91-2983
In Commercial Distribution

  • 10889981082055 ()

  • 4.8 x 250mm
91-2983

  • Spinal implant trial

Malibu - 10889981082048

Trial Rod, 4.8 x 110mm
SEASPINE ORTHOPEDICS CORPORATION
91-2982
In Commercial Distribution

  • 10889981082048 ()

  • 4.8 x 110mm
91-2982

  • Spinal implant trial

Malibu - 10889981082031

Trial Rod, 4.8 x 60mm
SEASPINE ORTHOPEDICS CORPORATION
91-2981
In Commercial Distribution

  • 10889981082031 ()

  • 4.8 x 60mm
91-2981

  • Spinal implant trial

Malibu - 10889981079307

COBALT LOCKING CAP, 8.0+
SEASPINE ORTHOPEDICS CORPORATION
76-0020
In Commercial Distribution

  • 10889981079307 ()
76-0020

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

Malibu - 10889981079291

COBALT LOCKING CAP
SEASPINE ORTHOPEDICS CORPORATION
76-0010
In Commercial Distribution

  • 10889981079291 ()
76-0010

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