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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™ - 10889981029753

PRECONTOURED ROD, 5.5 x 100mm
SEASPINE ORTHOPEDICS CORPORATION
12-1100
In Commercial Distribution

  • 10889981029753 ()

  • 5.5mm x 100mm
12-1100

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

Malibu™ - 10889981029739

CLOSED LATERAL CONNECTOR, 5.5/6.35 X 30MM
SEASPINE ORTHOPEDICS CORPORATION
12-0055
In Commercial Distribution

  • 10889981029739 ()

  • 5.5mm/6.35mm X 30MM
12-0055

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

Malibu™ - 10889981029715

ROD CONNECTOR, 6.35 x6.35
SEASPINE ORTHOPEDICS CORPORATION
12-0046
In Commercial Distribution

  • 10889981029715 ()

  • 6.35mm x 6.35mm
12-0046

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

Malibu™ - 10889981029678

CONTOURED CROSSBAR, LARGE, 5.5 ROD
SEASPINE ORTHOPEDICS CORPORATION
12-2075
In Commercial Distribution

  • 10889981029678 ()

  • LARGE, 5.5mm ROD
12-2075

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

Malibu™ - 10889981029647

PEDICLE HOOK, 9.0 X 9.5mm
SEASPINE ORTHOPEDICS CORPORATION
17-9095
In Commercial Distribution

  • 10889981029647 ()

  • 9.0mm X 9.5mm
17-9095

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

Malibu™ - 10889981029630

PEDICLE HOOK, 9.0 X 8.0mm
SEASPINE ORTHOPEDICS CORPORATION
17-9080
In Commercial Distribution

  • 10889981029630 ()

  • 9.0mm X 8.0mm
17-9080

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

Malibu™ - 10889981029623

PEDICLE HOOK, 9.0 X 6.5mm
SEASPINE ORTHOPEDICS CORPORATION
17-9065
In Commercial Distribution

  • 10889981029623 ()

  • 9.0mm X 6.5mm
17-9065

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

Malibu™ - 10889981029616

PEDICLE HOOK, 9.0 X 5.0mm
SEASPINE ORTHOPEDICS CORPORATION
17-9050
In Commercial Distribution

  • 10889981029616 ()

  • 9.0mm X 5.0mm
17-9050

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

Malibu™ - 10889981029609

PEDICLE HOOK, 7.5 X 9.5mm
SEASPINE ORTHOPEDICS CORPORATION
17-7595
In Commercial Distribution

  • 10889981029609 ()

  • 7.5mm X 9.5mm
17-7595

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

Malibu™ - 10889981029593

PEDICLE HOOK, 7.5 X 8.0mm
SEASPINE ORTHOPEDICS CORPORATION
17-7580
In Commercial Distribution

  • 10889981029593 ()

  • 7.5mm X 8.0mm
17-7580

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